Trial Outcomes & Findings for Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566 (NCT NCT02315066)

Last Updated: 2022-04-21

Results Overview

DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting \>7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

174 participants

Primary outcome timeframe

The first 2 cycles of treatment (Day 1 up to Day 28)

Results posted on

2022-04-21

Participant Flow

Part A (PF-04518600 monotherapy) included Part A1 and Part A2 Part B(PF-04518600 plus utomilumab \[PF-05082566\] combination therapy) included Part B1 and Part B2

A total of 174 participants were enrolled in this study, and 174 of them received study treatment. For Part A, 87 participants were enrolled and treated with PF-04518600 at several dose levels. For Part B, 87 participants were enrolled and treated with PF-04518600+utomilumab at several dose levels.

Participant milestones

Participant milestones
Measure	Part A1: PF-04518600 0.01mg/kg Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B2: PF-04518600 30mg + PF-05082566 20mg Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Overall Study STARTED	2	10	11	12	13	4	16	19	11	12	12	11	11	30
Overall Study COMPLETED	0	0	2	1	2	1	3	5	0	1	0	0	1	0
Overall Study NOT COMPLETED	2	10	9	11	11	3	13	14	11	11	12	11	10	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A1: PF-04518600 0.01mg/kg Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B2: PF-04518600 30mg + PF-05082566 20mg Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Overall Study Lost to Follow-up	0	1	1	0	1	0	2	1	0	0	1	2	0	4
Overall Study Death	2	7	6	11	10	3	9	9	10	8	10	7	8	21
Overall Study Other	0	0	0	0	0	0	0	1	1	2	0	0	0	0
Overall Study Subject refused further follow-up	0	2	2	0	0	0	2	3	0	1	1	2	2	4
Overall Study Study ongoing at date of cut-off	0	0	0	0	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg n=11 Participants Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg n=12 Participants Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg n=12 Participants Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg n=11 Participants Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg n=11 Participants Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B2: PF-04518600 30mg + PF-05082566 20mg n=30 Participants Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Total n=174 Participants Total of all reporting groups
Age, Customized Less than 18 years old	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	0 participants n=115 Participants	0 participants n=6 Participants	0 participants n=6 Participants	0 participants n=64 Participants	0 participants n=17 Participants	0 participants n=21 Participants	0 participants n=22 Participants	0 participants n=8 Participants	0 participants n=16 Participants
Age, Customized 18 to 44 years old (18-44)	0 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	0 participants n=115 Participants	1 participants n=6 Participants	2 participants n=6 Participants	0 participants n=64 Participants	1 participants n=17 Participants	0 participants n=21 Participants	0 participants n=22 Participants	3 participants n=8 Participants	11 participants n=16 Participants
Age, Customized 45 to 64 years old (45-64)	2 participants n=5 Participants	7 participants n=7 Participants	6 participants n=5 Participants	2 participants n=4 Participants	7 participants n=21 Participants	1 participants n=10 Participants	8 participants n=115 Participants	9 participants n=6 Participants	7 participants n=6 Participants	7 participants n=64 Participants	8 participants n=17 Participants	4 participants n=21 Participants	3 participants n=22 Participants	14 participants n=8 Participants	85 participants n=16 Participants
Age, Customized 65 years old and more than 65 years old (>＝65)	0 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	10 participants n=4 Participants	6 participants n=21 Participants	2 participants n=10 Participants	8 participants n=115 Participants	9 participants n=6 Participants	2 participants n=6 Participants	5 participants n=64 Participants	3 participants n=17 Participants	7 participants n=21 Participants	8 participants n=22 Participants	13 participants n=8 Participants	78 participants n=16 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=6 Participants	4 Participants n=6 Participants	4 Participants n=64 Participants	7 Participants n=17 Participants	3 Participants n=21 Participants	9 Participants n=22 Participants	10 Participants n=8 Participants	49 Participants n=16 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	11 Participants n=4 Participants	11 Participants n=21 Participants	4 Participants n=10 Participants	16 Participants n=115 Participants	16 Participants n=6 Participants	7 Participants n=6 Participants	8 Participants n=64 Participants	5 Participants n=17 Participants	8 Participants n=21 Participants	2 Participants n=22 Participants	20 Participants n=8 Participants	125 Participants n=16 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	4 Participants n=64 Participants	1 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	2 Participants n=8 Participants	16 Participants n=16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	13 Participants n=21 Participants	3 Participants n=10 Participants	8 Participants n=115 Participants	14 Participants n=6 Participants	9 Participants n=6 Participants	8 Participants n=64 Participants	11 Participants n=17 Participants	11 Participants n=21 Participants	11 Participants n=22 Participants	24 Participants n=8 Participants	143 Participants n=16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	8 Participants n=115 Participants	3 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	4 Participants n=8 Participants	15 Participants n=16 Participants
Race/Ethnicity, Customized WHITE	1 participants n=5 Participants	10 participants n=7 Participants	9 participants n=5 Participants	9 participants n=4 Participants	8 participants n=21 Participants	4 participants n=10 Participants	6 participants n=115 Participants	8 participants n=6 Participants	10 participants n=6 Participants	6 participants n=64 Participants	10 participants n=17 Participants	8 participants n=21 Participants	8 participants n=22 Participants	20 participants n=8 Participants	117 participants n=16 Participants
Race/Ethnicity, Customized BLACK	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	0 participants n=10 Participants	0 participants n=115 Participants	3 participants n=6 Participants	0 participants n=6 Participants	0 participants n=64 Participants	0 participants n=17 Participants	0 participants n=21 Participants	0 participants n=22 Participants	1 participants n=8 Participants	6 participants n=16 Participants
Race/Ethnicity, Customized ASIAN	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	4 participants n=21 Participants	0 participants n=10 Participants	2 participants n=115 Participants	5 participants n=6 Participants	1 participants n=6 Participants	2 participants n=64 Participants	2 participants n=17 Participants	3 participants n=21 Participants	3 participants n=22 Participants	4 participants n=8 Participants	30 participants n=16 Participants
Race/Ethnicity, Customized OTHER	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	1 participants n=115 Participants	1 participants n=6 Participants	0 participants n=6 Participants	4 participants n=64 Participants	0 participants n=17 Participants	0 participants n=21 Participants	0 participants n=22 Participants	3 participants n=8 Participants	10 participants n=16 Participants
Race/Ethnicity, Customized UNSPECIFIED	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	7 participants n=115 Participants	2 participants n=6 Participants	0 participants n=6 Participants	0 participants n=64 Participants	0 participants n=17 Participants	0 participants n=21 Participants	0 participants n=22 Participants	2 participants n=8 Participants	11 participants n=16 Participants
Body mass index	27.5 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 6.7 • n=5 Participants	26.6 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 3.6 • n=7 Participants	26.4 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 4.9 • n=5 Participants	28.9 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.7 • n=4 Participants	25.9 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 4.5 • n=21 Participants	22.8 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 1.9 • n=10 Participants	26.2 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 3.7 • n=115 Participants	25.5 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 6.0 • n=6 Participants	25.3 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.2 • n=6 Participants	26.7 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 7.6 • n=64 Participants	25.5 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 7.4 • n=17 Participants	25.0 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.2 • n=21 Participants	23.5 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.9 • n=22 Participants	25.2 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.3 • n=8 Participants	25.2 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.9 • n=16 Participants

PRIMARY outcome

Timeframe: The first 2 cycles of treatment (Day 1 up to Day 28)

Population: The population for this outcome measure included all enrolled participants who received at least two cycles of study medication and who did not have major treatment deviations during first two cycles.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: AEs: The informed consent date up to the last dosing date + 28 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.

Population: Analysis population included all enrolled participants who received at least one full or partial IV infusion of study drug PF-04518600.

Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A Number of Participants with all-causality TEAEs	2 Participants	10 Participants	11 Participants	12 Participants	13 Participants	4 Participants	16 Participants	19 Participants
Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A Number of Participants with treatment-related TEAEs	2 Participants	7 Participants	7 Participants	7 Participants	7 Participants	1 Participants	11 Participants	12 Participants
Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A Number of Participants with treatment-related SAEs	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A Number of Participants with all-causality SAEs	0 Participants	4 Participants	1 Participants	3 Participants	6 Participants	2 Participants	7 Participants	6 Participants

PRIMARY outcome

Timeframe: The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)

Population: Analysis Population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick \[protein, blood\], microscopy \[urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells\], miscellaneous \[urine casts and bacteria\]).

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=12 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Number of Participants With Laboratory Test Abnormalities in Part A Uric Acid (mg/dL) > 1.2 x ULN	0 Participants	3 Participants	2 Participants	2 Participants	3 Participants	1 Participants	2 Participants	4 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine RBC (/high power field (HPF)) >= 20	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Epithelial Cells (/HPF) >= 6	0 Participants	3 Participants	3 Participants	1 Participants	3 Participants	2 Participants	1 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Casts (/low power field(LPF) > 1	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Hyaline Casts (/LPF) >1	1 Participants	4 Participants	2 Participants	5 Participants	5 Participants	0 Participants	1 Participants	4 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Bacteria (/HPF) > 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A White Blood Cell Count (103/mm3) < 0.6 x LLN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Basophils (%) > 1.2 x ULN	0 Participants	2 Participants	3 Participants	1 Participants	2 Participants	1 Participants	2 Participants	4 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Eosinophils (Abs) (103/mm3) > 1.2 x ULN	1 Participants	0 Participants	3 Participants	1 Participants	3 Participants	0 Participants	2 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Eosinophils (%) > 1.2 x ULN	1 Participants	3 Participants	7 Participants	4 Participants	3 Participants	1 Participants	4 Participants	6 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Monocytes (Abs) (103/mm3) > 1.2 x ULN	0 Participants	2 Participants	3 Participants	4 Participants	2 Participants	3 Participants	0 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Monocytes (%) > 1.2 x ULN	1 Participants	4 Participants	3 Participants	10 Participants	8 Participants	1 Participants	5 Participants	12 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Prothrombin (PT) (sec) > 1.1 x ULN	0 Participants	0 Participants	2 Participants	5 Participants	2 Participants	2 Participants	4 Participants	6 Participants
Number of Participants With Laboratory Test Abnormalities in Part A PT International Ratio (INR) > 1.1 x ULN	0 Participants	0 Participants	2 Participants	5 Participants	1 Participants	0 Participants	5 Participants	6 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Total Bilirubin (mg/dL) > 1.5 x ULN	1 Participants	3 Participants	0 Participants	1 Participants	2 Participants	0 Participants	5 Participants	5 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Direct Bilirubin (mg/dL) > 1.5 x ULN	1 Participants	—	0 Participants	1 Participants	1 Participants	0 Participants	3 Participants	4 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Indirect Bilirubin (mg/dL) > 1.5 x ULN	—	—	—	0 Participants	—	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN	1 Participants	4 Participants	0 Participants	3 Participants	3 Participants	0 Participants	6 Participants	9 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN	0 Participants	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants	4 Participants	5 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Gamma GT (IU/L) > 3.0 x ULN	—	1 Participants	0 Participants	4 Participants	4 Participants	0 Participants	10 Participants	10 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Alkaline Phosphatase (IU/L) > 3.0 x ULN	0 Participants	3 Participants	0 Participants	4 Participants	3 Participants	0 Participants	5 Participants	7 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Albumin (g/dL) < 0.8 x LLN	0 Participants	0 Participants	1 Participants	4 Participants	2 Participants	2 Participants	1 Participants	4 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Albumin (g/dL) > 1.2 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN	1 Participants	2 Participants	2 Participants	3 Participants	4 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Creatinine (mg/dL) > 1.3 x ULN	0 Participants	1 Participants	2 Participants	1 Participants	3 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Sodium (milliequivalent (mEq/L) < 0.95 x LLN	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Sodium (mEq/L) > 1.05 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Potassium (mEq/L) < 0.9 x LLN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Potassium (mEq/L) > 1.1 x ULN	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Chloride (mEq/L) < 0.9 x LLN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Chloride (mEq/L) > 1.1 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Calcium (mg/dL) < 0.9 x LLN	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Calcium (mg/dL) > 1.1 x ULN	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Magnesium (mg/dL) < 0.9 x LLN	1 Participants	1 Participants	0 Participants	3 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Magnesium (mg/dL) > 1.1 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Phosphate (mg/dL) < 0.8 x LLN	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Phosphate (mg/dL) > 1.2 x ULN	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A T4 (free) (ng/dL) < 0.8 x LLN	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A T4 (free) (ng/dL) > 1.2 x ULN	—	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A TSH (UIU/mL) < 0.8 x LLN	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A TSH (UIU/mL) > 1.2 x ULN	—	0 Participants	0 Participants	1 Participants	2 Participants	2 Participants	3 Participants	6 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Glucose (mg/dL) < 0.6 x LLN	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Glucose (mg/dL) > 1.5 x ULN	0 Participants	6 Participants	2 Participants	5 Participants	4 Participants	1 Participants	9 Participants	5 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Creatine Kinase (CK) (U/L) > 2.0 x ULN	—	—	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Amylase (U/L) > 1.5 x ULN	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	5 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Lipase (U/L) > 1.5 x ULN	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	4 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Protein (Qual) >= 1	1 Participants	5 Participants	4 Participants	4 Participants	1 Participants	1 Participants	5 Participants	5 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Blood/ hemoglobin(Hgb) (Qual) >= 1	0 Participants	1 Participants	2 Participants	3 Participants	3 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine WBC (/HPF) >= 20	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Granular Casts (/LPF) > 1	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Total Neutrophils (Abs) (103/mm3) < 0.8 x LLN	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN)	0 Participants	2 Participants	4 Participants	6 Participants	4 Participants	2 Participants	10 Participants	4 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Hematocrit (%) < 0.8 x LLN	0 Participants	1 Participants	2 Participants	4 Participants	5 Participants	3 Participants	8 Participants	5 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Platelets (103/mm3) < 0.5 x LLN	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Platelets (103/mm3) > 1.75 x upper limit of normal (ULN)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A White Blood Cell Count (103/mm3) > 1.5 x ULN	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Lymphocytes (Absolute(Abs)) (103/mm3) < 0.8 x LLN	1 Participants	2 Participants	2 Participants	5 Participants	4 Participants	4 Participants	6 Participants	8 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Lymphocytes (Abs) (103/mm3) > 1.2 x ULN	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Lymphocytes (%) < 0.8 x LLN	2 Participants	7 Participants	5 Participants	7 Participants	9 Participants	4 Participants	9 Participants	10 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Lymphocytes (%) > 1.2 x ULN	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Total Neutrophils (Abs) (103/mm3) > 1.2 x LLN	0 Participants	1 Participants	1 Participants	2 Participants	6 Participants	3 Participants	1 Participants	5 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Neutrophils (%) <0.8x LLN	—	—	—	—	—	—	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Neutrophils (%) >1.2x ULN	—	—	—	—	—	—	1 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities in Part A PTT (sec) > 1.1 x ULN	2 Participants	2 Participants	4 Participants	4 Participants	3 Participants	1 Participants	3 Participants	4 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Basophils (Abs) (103/mm3) > 1.2 x ULN	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: The First 2 Cycles of Treatment (Day 1 up to Day 28)

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=11 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Number of Participants With DLTs in Part B1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: AEs: The informed consent date up to the last dosing date + 60 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=11 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=30 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B Number of Participants with treatment-related SAEs	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B Number of Participants with all-causality TEAEs	11 Participants	12 Participants	12 Participants	11 Participants	11 Participants	30 Participants	—	—
Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B Number of Participants with treatment-related TEAEs	4 Participants	6 Participants	7 Participants	5 Participants	7 Participants	22 Participants	—	—
Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B Number of Participants with all-causality SAEs	5 Participants	2 Participants	3 Participants	5 Participants	5 Participants	10 Participants	—	—

PRIMARY outcome

Timeframe: The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=10 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=11 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=30 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Number of Participants With Laboratory Test Abnormalities in Part B Platelets (103/mm3) < 0.5 x LLN	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B PTT (sec) > 1.1 x ULN	3 Participants	1 Participants	3 Participants	4 Participants	2 Participants	7 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Gamma GT (IU/L) > 3.0 x ULN	1 Participants	0 Participants	2 Participants	2 Participants	2 Participants	5 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Albumin (g/dL) > 1.2 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Potassium (mEq/L) < 0.9 x LLN	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Chloride (mEq/L) < 0.9 x LLN	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Chloride (mEq/L) > 1.1 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Calcium (mg/dL) < 0.9 x LLN	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Calcium (mg/dL) > 1.1 x ULN	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Magnesium (mg/dL) < 0.9 x LLN	1 Participants	1 Participants	4 Participants	2 Participants	1 Participants	3 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Magnesium (mg/dL) > 1.1 x ULN	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Phosphate (mg/dL) < 0.8 x LLN	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	2 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Phosphate (mg/dL) > 1.2 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B T4 (free) (ng/dL) < 0.8 x LLN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Urine Protein (Qual) >= 1	2 Participants	5 Participants	4 Participants	2 Participants	4 Participants	7 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Urine Blood/Hgb (Qual) >= 1	2 Participants	5 Participants	4 Participants	1 Participants	3 Participants	7 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Urine RBC (/HPF) >= 20	1 Participants	3 Participants	1 Participants	2 Participants	2 Participants	4 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Urine WBC (/HPF) >= 20	2 Participants	4 Participants	4 Participants	3 Participants	2 Participants	7 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Urine Epithelial Cells (/HPF) >= 6	5 Participants	5 Participants	2 Participants	2 Participants	2 Participants	6 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Urine Casts (/LPF) > 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Lymphocytes (%) < 0.8 x LLN	8 Participants	8 Participants	9 Participants	9 Participants	9 Participants	20 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Lymphocytes (%) > 1.2 x ULN	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Total Neutrophils (Abs) (103/mm3) < 0.8 x LLN	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Total Neutrophils (Abs) (103/mm3) > 1.2 x LLN	3 Participants	5 Participants	5 Participants	7 Participants	5 Participants	15 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Neutrophils (%) <0.8x LLN	—	—	—	—	—	2 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Neutrophils (%) >1.2x ULN	—	—	—	—	—	6 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Basophils (Abs) (103/mm3) > 1.2 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	5 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Basophils (%) > 1.2 x ULN	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Eosinophils (Abs) (103/mm3) > 1.2 x ULN	1 Participants	3 Participants	6 Participants	4 Participants	3 Participants	12 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Eosinophils (%) > 1.2 x ULN	1 Participants	3 Participants	6 Participants	3 Participants	4 Participants	14 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Monocytes (Abs) (103/mm3) > 1.2 x ULN	1 Participants	4 Participants	5 Participants	6 Participants	5 Participants	9 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Monocytes (%) > 1.2 x ULN	3 Participants	3 Participants	3 Participants	6 Participants	3 Participants	9 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Prothrombin (PT) (sec) > 1.1 x ULN	1 Participants	3 Participants	2 Participants	3 Participants	3 Participants	11 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B PT International Ratio (INR) > 1.1 x ULN	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Total Bilirubin (mg/dL) > 1.5 x ULN	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Direct Bilirubin (mg/dL) > 1.5 x ULN	—	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Indirect Bilirubin (mg/dL) > 1.5 x ULN	—	—	0 Participants	—	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Alkaline Phosphatase (IU/L) > 3.0 x ULN	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Albumin (g/dL) < 0.8 x LLN	1 Participants	0 Participants	2 Participants	3 Participants	3 Participants	3 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN	1 Participants	2 Participants	2 Participants	1 Participants	1 Participants	5 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Creatinine (mg/dL) > 1.3 x ULN	1 Participants	1 Participants	3 Participants	0 Participants	1 Participants	2 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Uric Acid (mg/dL) > 1.2 x ULN	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Sodium (mEq/L) < 0.95 x LLN	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants	2 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Sodium (mEq/L) > 1.05 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Potassium (mEq/L) > 1.1 x ULN	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	5 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN)	4 Participants	3 Participants	4 Participants	7 Participants	6 Participants	9 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Hematocrit (%) < 0.8 x LLN	4 Participants	2 Participants	3 Participants	6 Participants	4 Participants	4 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Platelets (103/mm3) > 1.75 x upper limit of normal (ULN)	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B White Blood Cell Count (103/mm3) < 0.6 x LLN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B White Blood Cell Count (103/mm3) > 1.5 x ULN	0 Participants	1 Participants	4 Participants	2 Participants	3 Participants	6 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Lymphocytes (Abs) (103/mm3) < 0.8 x LLN	5 Participants	5 Participants	8 Participants	6 Participants	6 Participants	10 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Lymphocytes (Abs) (103/mm3) > 1.2 x ULN	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B TSH (UIU/mL) < 0.8 x LLN	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	4 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B TSH (UIU/mL) > 1.2 x ULN	2 Participants	3 Participants	4 Participants	4 Participants	3 Participants	5 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Glucose (mg/dL) < 0.6 x LLN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Glucose (mg/dL) > 1.5 x ULN	0 Participants	3 Participants	3 Participants	2 Participants	1 Participants	10 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Creatine Kinase (CK) (U/L) > 2.0 x ULN	—	—	—	0 Participants	—	0 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Amylase (U/L) > 1.5 x ULN	2 Participants	1 Participants	2 Participants	0 Participants	0 Participants	3 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Lipase (U/L) > 1.5 x ULN	1 Participants	3 Participants	2 Participants	0 Participants	0 Participants	7 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B T4 (free) (ng/dL) > 1.2 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Urine Granular Casts (/LPF) > 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Urine Hyaline Casts (/LPF) >1	1 Participants	2 Participants	2 Participants	0 Participants	4 Participants	5 Participants	—	—
Number of Participants With Laboratory Test Abnormalities in Part B Urine Bacteria (/HPF) > 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.

ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set. CR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to \<10 mm. PR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. Overall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A ORR per RECIST v1.1	0 percentage of participants	10 percentage of participants	9.1 percentage of participants	0 percentage of participants	0 percentage of participants	25 percentage of participants	0 percentage of participants	0 percentage of participants
Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A ORR per irRECIST	0 percentage of participants	10 percentage of participants	9.1 percentage of participants	0 percentage of participants	0 percentage of participants	25 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.

PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause. PD was progression documented after start date and not qualifying as CR, PR or SD per RECIST.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A	1.3 months Interval 1.3 to 1.4	3.5 months Interval 1.3 to 4.2	5.4 months Interval 1.3 to 24.0	1.4 months Interval 1.3 to 8.3	2.7 months Interval 1.3 to 5.6	4.8 months Interval 0.7 to The upper limit was not estimable. Because the upper limit for PFS based on Kaplan-Meier method was not reached.	3.0 months Interval 1.5 to 3.7	2.8 months Interval 1.7 to 3.6

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.

TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A	1.3 months Interval 1.3 to 1.4	4.1 months Interval 1.3 to 6.5	5.4 months Interval 1.3 to 24.0	1.4 months Interval 1.3 to 8.3	3.2 months Interval 1.2 to 5.6	8.3 months Interval 1.2 to The upper limit was not estimable. Because the upper limit for TTP based on Kaplan-Meier method was not reached.	3.2 months Interval 1.5 to 3.7	2.8 months Interval 1.7 to 3.6

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.

SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Number of Participants Having Stable Disease (SD) in Part A	0 Participants	5 Participants	6 Participants	6 Participants	8 Participants	1 Participants	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.

DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response. CR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \<10 mm) and all target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A	NA months Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.	2.4 months Ranges for 95% CI were not estimable due to less than 50% participants in this cohort achieved CR or PR.	21.4 months Ranges for 95% CI were not estimable due to less than 50% participants in this cohort achieved CR or PR.	NA months Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.	NA months Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.	NA months Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.	NA months Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.	NA months Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.

OS was defined as time in months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 30.44.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A	11 months Interval 7.3 to 14.8	13.0 months Interval 3.3 to 20.7	17.6 months Interval 4.1 to The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.	9.0 months Interval 3.8 to 17.2	7.4 months Interval 5.1 to 19.1	7.5 months Interval 0.7 to The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.	15.6 months Interval 4.2 to The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.	23.9 months Interval 6.5 to The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.

Probability of survival at 6, 12, and 24 months after the first dose of study treatment.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Overall Survival Rates at Months 6, 12, and 24 in Part A Survival Probability at Month 6	100 Probability of survival Interval 100.0 to 100.0	68.6 Probability of survival Interval 30.5 to 88.7	88.9 Probability of survival Interval 43.3 to 98.4	75.0 Probability of survival Interval 40.8 to 91.2	67.7 Probability of survival Interval 34.9 to 86.5	50.0 Probability of survival Interval 5.8 to 84.5	62.5 Probability of survival Interval 31.7 to 82.5	83.9 Probability of survival Interval 57.9 to 94.5
Overall Survival Rates at Months 6, 12, and 24 in Part A Survival Probability at Month 12	50.0 Probability of survival Interval 0.6 to 91.0	51.4 Probability of survival Interval 14.3 to 79.6	55.6 Probability of survival Interval 20.4 to 80.5	41.7 Probability of survival Interval 15.2 to 66.5	33.8 Probability of survival Interval 10.5 to 59.4	50.0 Probability of survival Interval 5.8 to 84.5	54.7 Probability of survival Interval 25.4 to 76.6	58.4 Probability of survival Interval 31.6 to 77.8
Overall Survival Rates at Months 6, 12, and 24 in Part A Survival Probability at Month 24	NA Probability of survival Number and ranges for 95% CI were not estimable due to both participants in the group have been censored or died before month 24.	NA Probability of survival Number and ranges for 95% CI were not estimable due to all participants in the group have been censored or died before month 24.	44.4 Probability of survival Interval 13.6 to 71.9	NA Probability of survival Number and ranges for 95% CI were not estimable due to all participants in the group have been censored or died before month 24.	16.9 Probability of survival Interval 2.7 to 41.7	25.0 Probability of survival Interval 0.9 to 66.5	27.3 Probability of survival Interval 6.9 to 53.4	42.6 Probability of survival Interval 17.7 to 65.7

SECONDARY outcome

Timeframe: For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.

Population: The pharmacokinetic (PK) parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmax.

Cmax was defined as maximum observed serum concentration and can be observed directly from data. Css,max was the Cmax on C3D1.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=1 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=10 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A CYCLE1/DAY1	0.231 microgram/milliliter (µg/mL) Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	2.871 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 24	8.448 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 17	36.71 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 21	75.91 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 18	268.1 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 20	8.264 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 25	72.05 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 22
Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A CYCLE3/DAY1	—	2.731 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 54	11.03 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 23	56.15 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 19	114.9 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 22	401.1 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 26	10.27 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 32	105.7 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 23

SECONDARY outcome

Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCtau.

AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=1 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=10 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A CYCLE1/DAY1	7.59 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	303.5 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 35	1350 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 20	6218 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 23	12810 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 17	38220 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 19	1375 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 25	14360 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 19
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A CYCLE3/DAY1	—	299 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 151	2072 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 36	11610 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 18	25600 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 21	82710 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 32	2236 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 37	25380 microgram•hour/milliliter (µg•hr/mL) Geometric Coefficient of Variation 29

SECONDARY outcome

AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=1 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=10 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A CYCLE1/DAY1	—	293.7 μg*hr/mL Geometric Coefficient of Variation 34	NA μg*hr/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1590,1010.	—	23000 μg*hr/mL Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	—	NA μg*hr/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1580,991.	22700 μg*hr/mL Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A CYCLE3/DAY1	—	380.7 μg*hr/mL Geometric Coefficient of Variation 56	—	—	33800 μg*hr/mL Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	—	1180 μg*hr/mL Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	35000 μg*hr/mL Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.

SECONDARY outcome

t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=1 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=10 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A CYCLE1/DAY1	—	3.410 days Standard Deviation 1.0992	NA days Standard Deviation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 5.77,4.83.	—	13.1 days Standard Deviation NA Geometric CV was not calculated for n\<3.	—	5.67 days Standard Deviation 5.89	11.9 days Standard Deviation NA Geometric CV was not calculated for n\<3.
Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A CYCLE3/DAY1	—	4.010 days Standard Deviation 1.1370	—	—	10.6 days Standard Deviation NA Geometric CV was not calculated for n\<3.	—	5.76 days Standard Deviation NA Geometric CV was not calculated for n\<3.	11.9 days Standard Deviation NA Geometric CV was not calculated for n\<3.

SECONDARY outcome

Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=9 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=9 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=3 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=15 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=16 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A.	—	0.05952 ug/mL Geometric Coefficient of Variation 51749	2.882 ug/mL Geometric Coefficient of Variation 61	17.79 ug/mL Geometric Coefficient of Variation 32	36.14 ug/mL Geometric Coefficient of Variation 48	130 ug/mL Geometric Coefficient of Variation 41	2.968 ug/mL Geometric Coefficient of Variation 55	37.62 ug/mL Geometric Coefficient of Variation 47

SECONDARY outcome

Cav was defined as average serum concentration over the dosing interval.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=8 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=7 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=7 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=8 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=3 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=14 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=15 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A	—	0.8897 µg/mL Geometric Coefficient of Variation 151	6.166 µg/mL Geometric Coefficient of Variation 36	34.55 µg/mL Geometric Coefficient of Variation 18	76.13 µg/mL Geometric Coefficient of Variation 20	246.1 µg/mL Geometric Coefficient of Variation 32	6.659 µg/mL Geometric Coefficient of Variation 37	75.55 µg/mL Geometric Coefficient of Variation 29

SECONDARY outcome

Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=8 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=7 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=7 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=8 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=3 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=14 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=15 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A	—	0.3342 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 151	0.1448 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 48	0.1291 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 18	0.1171 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 21	0.1209 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 32	0.1739 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 28	0.1423 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 31

SECONDARY outcome

Vss was defined as volume of distribution at steady state.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=5 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=1 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=1 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=1 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A.	—	39.17 milliliter/kilograms (mL/kg) Geometric Coefficient of Variation 19	—	—	55.3 milliliter/kilograms (mL/kg) Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	—	79.2 milliliter/kilograms (mL/kg) Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	94.3 milliliter/kilograms (mL/kg) Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.

SECONDARY outcome

Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=8 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=6 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=7 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=8 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=3 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=14 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=15 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A	—	0.9893 ratio Geometric Coefficient of Variation 110	1.543 ratio Geometric Coefficient of Variation 32	1.785 ratio Geometric Coefficient of Variation 12	1.947 ratio Geometric Coefficient of Variation 12	2.161 ratio Geometric Coefficient of Variation 13	1.628 ratio Geometric Coefficient of Variation 19	1.709 ratio Geometric Coefficient of Variation 21

SECONDARY outcome

Timeframe: Baseline up to end of treatment (maximum of 14 weeks).

Population: The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.

ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 Participants Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 Participants Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A ADA ever-positive	2 Participants	9 Participants	5 Participants	2 Participants	0 Participants	0 Participants	7 Participants	0 Participants
Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A NAb ever-positive	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose, 4 and 24 hours post dose on Cycle 1 Day 1, and Day 8 on Cycles 1 to 3, then pre-dose on Cycles 4 and 7 and end of treatment in Part A1

Population: Analysis Population included all enrolled participants with at least 1 of the OX40 evaluated at pre and/or post dose.

Mean unbound cell surface OX40 in peripheral blood was measured to characterize the degree of target engagement (TE) by PF-04518600 at baseline and multiple doses.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=8 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=10 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=9 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=8 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)	54.65 percentage of baseline concentration Standard Deviation 15.203	51.54 percentage of baseline concentration Standard Deviation 15.670	44.85 percentage of baseline concentration Standard Deviation 9.407	41.53 percentage of baseline concentration Standard Deviation 11.797	48.45 percentage of baseline concentration Standard Deviation 18.597	47.60 percentage of baseline concentration Standard Deviation 12.181	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose)	49.25 percentage of baseline concentration Standard Deviation 21.708	27.44 percentage of baseline concentration Standard Deviation 24.644	2.39 percentage of baseline concentration Standard Deviation 3.102	0.04 percentage of baseline concentration Standard Deviation 0.223	0.56 percentage of baseline concentration Standard Deviation 0.940	-0.20 percentage of baseline concentration Standard Deviation 0.424	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 8	35.15 percentage of baseline concentration Standard Deviation 35.426	17.42 percentage of baseline concentration Standard Deviation 18.026	1.03 percentage of baseline concentration Standard Deviation 2.177	0.04 percentage of baseline concentration Standard Deviation 0.151	0.44 percentage of baseline concentration Standard Deviation 1.043	-0.27 percentage of baseline concentration Standard Deviation 0.379	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Central Memory T Cells (%) End of treatment	53.20 percentage of baseline concentration Standard Deviation 1.838	31.13 percentage of baseline concentration Standard Deviation 22.871	0.23 percentage of baseline concentration Standard Deviation 0.252	-0.18 percentage of baseline concentration Standard Deviation 0.150	0.85 percentage of baseline concentration Standard Deviation 1.061	—	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose)	66.95 percentage of baseline concentration Standard Deviation 22.698	57.26 percentage of baseline concentration Standard Deviation 18.236	55.18 percentage of baseline concentration Standard Deviation 10.939	45.67 percentage of baseline concentration Standard Deviation 12.565	42.72 percentage of baseline concentration Standard Deviation 9.957	49.25 percentage of baseline concentration Standard Deviation 15.295	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2	44.35 percentage of baseline concentration Standard Deviation 36.275	6.33 percentage of baseline concentration Standard Deviation 5.863	2.70 percentage of baseline concentration Standard Deviation 3.344	0.10 percentage of baseline concentration Standard Deviation 0.238	0.01 percentage of baseline concentration Standard Deviation 0.107	-0.05 percentage of baseline concentration Standard Deviation 0.071	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8	61.40 percentage of baseline concentration Standard Deviation 21.072	11.50 percentage of baseline concentration Standard Deviation 8.179	1.34 percentage of baseline concentration Standard Deviation 1.646	0.66 percentage of baseline concentration Standard Deviation 1.037	0.42 percentage of baseline concentration Standard Deviation 0.624	0.08 percentage of baseline concentration Standard Deviation 0.222	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose)	51.55 percentage of baseline concentration Standard Deviation 0.495	20.17 percentage of baseline concentration Standard Deviation 12.575	4.83 percentage of baseline concentration Standard Deviation 3.810	1.13 percentage of baseline concentration Standard Deviation 1.908	0.58 percentage of baseline concentration Standard Deviation 0.697	-0.10 percentage of baseline concentration Standard Deviation 0.173	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8	45.95 percentage of baseline concentration Standard Deviation 41.083	24.00 percentage of baseline concentration Standard Deviation 18.939	2.99 percentage of baseline concentration Standard Deviation 4.632	0.11 percentage of baseline concentration Standard Deviation 0.393	0.18 percentage of baseline concentration Standard Deviation 0.349	-0.03 percentage of baseline concentration Standard Deviation 0.115	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose)	21.10 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of free CD4+ effector memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.	24.52 percentage of baseline concentration Standard Deviation 22.304	1.98 percentage of baseline concentration Standard Deviation 1.096	0.13 percentage of baseline concentration Standard Deviation 0.231	0.17 percentage of baseline concentration Standard Deviation 0.289	0.15 percentage of baseline concentration Standard Deviation 0.071	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Effector Memory T Cells (%) End of treatment	58.05 percentage of baseline concentration Standard Deviation 9.263	47.80 percentage of baseline concentration Standard Deviation 21.140	0.27 percentage of baseline concentration Standard Deviation 0.351	0.15 percentage of baseline concentration Standard Deviation 0.436	0.50 percentage of baseline concentration Standard Deviation 0.424	—	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)	8.20 percentage of baseline concentration Standard Deviation 0.566	9.77 percentage of baseline concentration Standard Deviation 11.267	5.50 percentage of baseline concentration Standard Deviation 4.018	12.52 percentage of baseline concentration Standard Deviation 8.946	8.95 percentage of baseline concentration Standard Deviation 6.649	18.73 percentage of baseline concentration Standard Deviation 18.566	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 2	3.90 percentage of baseline concentration Standard Deviation 1.273	0.59 percentage of baseline concentration Standard Deviation 1.415	0.23 percentage of baseline concentration Standard Deviation 0.674	0.03 percentage of baseline concentration Standard Deviation 1.021	0.17 percentage of baseline concentration Standard Deviation 0.836	-0.20 percentage of baseline concentration Standard Deviation 0.141	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 8	3.20 percentage of baseline concentration Standard Deviation 1.273	3.01 percentage of baseline concentration Standard Deviation 4.378	0.54 percentage of baseline concentration Standard Deviation 1.381	-0.23 percentage of baseline concentration Standard Deviation 0.699	1.13 percentage of baseline concentration Standard Deviation 3.862	-0.00 percentage of baseline concentration Standard Deviation 0.408	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose)	2.75 percentage of baseline concentration Standard Deviation 3.465	3.91 percentage of baseline concentration Standard Deviation 2.967	0.19 percentage of baseline concentration Standard Deviation 0.937	0.31 percentage of baseline concentration Standard Deviation 0.825	1.67 percentage of baseline concentration Standard Deviation 4.089	-0.20 percentage of baseline concentration Standard Deviation 0.985	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 8	4.50 percentage of baseline concentration Standard Deviation 0.566	3.08 percentage of baseline concentration Standard Deviation 2.994	0.31 percentage of baseline concentration Standard Deviation 0.965	-0.20 percentage of baseline concentration Standard Deviation 0.673	1.20 percentage of baseline concentration Standard Deviation 3.333	0.50 percentage of baseline concentration Standard Deviation 0.600	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2	1.05 percentage of baseline concentration Standard Deviation 0.495	0.36 percentage of baseline concentration Standard Deviation 0.519	0.05 percentage of baseline concentration Standard Deviation 0.105	0.04 percentage of baseline concentration Standard Deviation 0.151	0.41 percentage of baseline concentration Standard Deviation 1.057	-0.10 percentage of baseline concentration Standard Deviation 0.000	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose)	—	4.28 percentage of baseline concentration Standard Deviation 4.129	0.27 percentage of baseline concentration Standard Deviation 0.462	0.20 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of free CD8+ effector memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.	1.13 percentage of baseline concentration Standard Deviation 1.966	-0.10 percentage of baseline concentration Standard Deviation 0.000	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose)	28.85 percentage of baseline concentration Standard Deviation 0.778	40.18 percentage of baseline concentration Standard Deviation 12.164	34.51 percentage of baseline concentration Standard Deviation 10.649	42.13 percentage of baseline concentration Standard Deviation 18.565	41.98 percentage of baseline concentration Standard Deviation 12.160	38.35 percentage of baseline concentration Standard Deviation 9.019	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose)	31.30 percentage of baseline concentration Standard Deviation 1.980	35.28 percentage of baseline concentration Standard Deviation 14.278	34.92 percentage of baseline concentration Standard Deviation 5.867	40.88 percentage of baseline concentration Standard Deviation 11.313	45.69 percentage of baseline concentration Standard Deviation 6.950	38.43 percentage of baseline concentration Standard Deviation 6.543	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 8	49.75 percentage of baseline concentration Standard Deviation 18.880	46.47 percentage of baseline concentration Standard Deviation 14.885	39.07 percentage of baseline concentration Standard Deviation 13.011	45.09 percentage of baseline concentration Standard Deviation 10.489	38.22 percentage of baseline concentration Standard Deviation 20.166	27.70 percentage of baseline concentration Standard Deviation 13.124	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose)	37.20 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of total CD4+ central memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.	47.52 percentage of baseline concentration Standard Deviation 15.688	41.42 percentage of baseline concentration Standard Deviation 11.115	43.43 percentage of baseline concentration Standard Deviation 5.788	30.37 percentage of baseline concentration Standard Deviation 15.309	32.15 percentage of baseline concentration Standard Deviation 19.304	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Central Memory T Cells (%) End of treatment	52.75 percentage of baseline concentration Standard Deviation 13.789	46.70 percentage of baseline concentration Standard Deviation 12.775	24.80 percentage of baseline concentration Standard Deviation 23.435	41.38 percentage of baseline concentration Standard Deviation 6.111	34.65 percentage of baseline concentration Standard Deviation 11.526	—	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H)	60.65 percentage of baseline concentration Standard Deviation 17.607	58.76 percentage of baseline concentration Standard Deviation 16.535	50.53 percentage of baseline concentration Standard Deviation 13.385	47.82 percentage of baseline concentration Standard Deviation 15.437	31.28 percentage of baseline concentration Standard Deviation 15.021	38.68 percentage of baseline concentration Standard Deviation 19.538	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2	57.00 percentage of baseline concentration Standard Deviation 19.658	59.39 percentage of baseline concentration Standard Deviation 15.181	52.93 percentage of baseline concentration Standard Deviation 9.347	37.09 percentage of baseline concentration Standard Deviation 14.705	31.91 percentage of baseline concentration Standard Deviation 17.122	24.25 percentage of baseline concentration Standard Deviation 19.728	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8	56.20 percentage of baseline concentration Standard Deviation 18.526	50.57 percentage of baseline concentration Standard Deviation 12.243	45.09 percentage of baseline concentration Standard Deviation 11.917	44.00 percentage of baseline concentration Standard Deviation 13.558	31.87 percentage of baseline concentration Standard Deviation 18.013	33.43 percentage of baseline concentration Standard Deviation 10.754	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose)	44.00 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of total CD4+ effector memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.	49.92 percentage of baseline concentration Standard Deviation 11.834	48.54 percentage of baseline concentration Standard Deviation 14.165	51.03 percentage of baseline concentration Standard Deviation 10.119	29.60 percentage of baseline concentration Standard Deviation 7.754	33.40 percentage of baseline concentration Standard Deviation 30.830	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose)	—	55.98 percentage of baseline concentration Standard Deviation 10.071	38.67 percentage of baseline concentration Standard Deviation 12.438	44.80 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of total CD4+ effector memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.	22.10 percentage of baseline concentration Standard Deviation 18.857	59.75 percentage of baseline concentration Standard Deviation 12.092	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 2	7.30 percentage of baseline concentration Standard Deviation 5.940	10.33 percentage of baseline concentration Standard Deviation 9.138	8.65 percentage of baseline concentration Standard Deviation 6.783	12.27 percentage of baseline concentration Standard Deviation 10.298	11.93 percentage of baseline concentration Standard Deviation 8.826	23.95 percentage of baseline concentration Standard Deviation 34.295	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 8	4.50 percentage of baseline concentration Standard Deviation 1.131	9.53 percentage of baseline concentration Standard Deviation 7.607	9.03 percentage of baseline concentration Standard Deviation 10.168	15.81 percentage of baseline concentration Standard Deviation 9.926	9.55 percentage of baseline concentration Standard Deviation 7.987	10.65 percentage of baseline concentration Standard Deviation 15.910	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose)	8.70 percentage of baseline concentration Standard Deviation 7.495	9.56 percentage of baseline concentration Standard Deviation 10.163	9.50 percentage of baseline concentration Standard Deviation 12.278	14.83 percentage of baseline concentration Standard Deviation 11.588	10.42 percentage of baseline concentration Standard Deviation 7.695	2.67 percentage of baseline concentration Standard Deviation 1.570	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 8	8.70 percentage of baseline concentration Standard Deviation 5.798	12.13 percentage of baseline concentration Standard Deviation 11.505	10.19 percentage of baseline concentration Standard Deviation 13.521	12.89 percentage of baseline concentration Standard Deviation 8.212	10.38 percentage of baseline concentration Standard Deviation 10.295	2.77 percentage of baseline concentration Standard Deviation 3.109	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose)	5.90 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of total CD8+ central memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not be calculated.	11.54 percentage of baseline concentration Standard Deviation 10.077	13.42 percentage of baseline concentration Standard Deviation 8.546	13.60 percentage of baseline concentration Standard Deviation 10.942	12.07 percentage of baseline concentration Standard Deviation 12.360	4.75 percentage of baseline concentration Standard Deviation 3.041	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose)	—	16.35 percentage of baseline concentration Standard Deviation 10.850	8.03 percentage of baseline concentration Standard Deviation 1.528	21.60 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of total CD8+ central memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation valuewas not calculated.	11.97 percentage of baseline concentration Standard Deviation 12.051	6.30 percentage of baseline concentration Standard Deviation 2.263	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2	2.60 percentage of baseline concentration Standard Deviation 0.990	5.19 percentage of baseline concentration Standard Deviation 3.873	2.73 percentage of baseline concentration Standard Deviation 2.004	3.57 percentage of baseline concentration Standard Deviation 4.130	3.14 percentage of baseline concentration Standard Deviation 3.347	11.70 percentage of baseline concentration Standard Deviation 15.839	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8	2.60 percentage of baseline concentration Standard Deviation 1.273	3.54 percentage of baseline concentration Standard Deviation 2.463	3.36 percentage of baseline concentration Standard Deviation 5.108	4.50 percentage of baseline concentration Standard Deviation 4.727	2.57 percentage of baseline concentration Standard Deviation 3.222	17.88 percentage of baseline concentration Standard Deviation 20.990	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose)	3.25 percentage of baseline concentration Standard Deviation 2.616	4.70 percentage of baseline concentration Standard Deviation 4.031	3.77 percentage of baseline concentration Standard Deviation 6.125	4.53 percentage of baseline concentration Standard Deviation 4.511	3.12 percentage of baseline concentration Standard Deviation 3.539	13.10 percentage of baseline concentration Standard Deviation 19.341	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8	2.65 percentage of baseline concentration Standard Deviation 0.778	3.90 percentage of baseline concentration Standard Deviation 3.524	3.56 percentage of baseline concentration Standard Deviation 5.524	4.06 percentage of baseline concentration Standard Deviation 4.008	4.16 percentage of baseline concentration Standard Deviation 5.786	19.07 percentage of baseline concentration Standard Deviation 30.641	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose)	2.50 percentage of baseline concentration Standard Deviation 1.697	5.14 percentage of baseline concentration Standard Deviation 4.446	3.69 percentage of baseline concentration Standard Deviation 5.607	4.33 percentage of baseline concentration Standard Deviation 3.693	3.14 percentage of baseline concentration Standard Deviation 3.884	30.45 percentage of baseline concentration Standard Deviation 38.537	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8	2.70 percentage of baseline concentration Standard Deviation 0.990	4.48 percentage of baseline concentration Standard Deviation 4.388	3.50 percentage of baseline concentration Standard Deviation 5.568	4.57 percentage of baseline concentration Standard Deviation 4.340	3.64 percentage of baseline concentration Standard Deviation 3.832	18.67 percentage of baseline concentration Standard Deviation 27.050	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose)	—	6.18 percentage of baseline concentration Standard Deviation 4.811	2.60 percentage of baseline concentration Standard Deviation 1.952	7.80 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of total CD8+ effector memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.	3.67 percentage of baseline concentration Standard Deviation 5.755	35.40 percentage of baseline concentration Standard Deviation 46.528	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Effector Memory T Cells (%) End of treatment	1.70 percentage of baseline concentration Standard Deviation 0.141	3.93 percentage of baseline concentration Standard Deviation 4.957	0.57 percentage of baseline concentration Standard Deviation 0.306	1.95 percentage of baseline concentration Standard Deviation 1.605	1.25 percentage of baseline concentration Standard Deviation 1.061	—	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose)	35.70 percentage of baseline concentration Standard Deviation 5.940	42.29 percentage of baseline concentration Standard Deviation 13.590	36.97 percentage of baseline concentration Standard Deviation 7.219	45.23 percentage of baseline concentration Standard Deviation 11.181	49.74 percentage of baseline concentration Standard Deviation 10.086	40.57 percentage of baseline concentration Standard Deviation 3.415	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 8	30.95 percentage of baseline concentration Standard Deviation 3.465	44.45 percentage of baseline concentration Standard Deviation 14.962	40.53 percentage of baseline concentration Standard Deviation 6.707	46.71 percentage of baseline concentration Standard Deviation 10.444	56.66 percentage of baseline concentration Standard Deviation 12.388	39.93 percentage of baseline concentration Standard Deviation 16.671	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 8	34.30 percentage of baseline concentration Standard Deviation 3.536	38.83 percentage of baseline concentration Standard Deviation 8.536	35.78 percentage of baseline concentration Standard Deviation 13.922	41.69 percentage of baseline concentration Standard Deviation 10.489	47.16 percentage of baseline concentration Standard Deviation 13.427	41.70 percentage of baseline concentration Standard Deviation 13.089	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, FOXP3+ Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose)	—	41.80 percentage of baseline concentration Standard Deviation 3.149	41.23 percentage of baseline concentration Standard Deviation 6.725	28.70 percentage of baseline concentration Standard Deviation 0.849	43.40 percentage of baseline concentration Standard Deviation 5.145	52.35 percentage of baseline concentration Standard Deviation 15.344	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, FOXP3+ Regulatory T Cells (%) End of treatment	38.50 percentage of baseline concentration Standard Deviation 3.960	37.88 percentage of baseline concentration Standard Deviation 15.626	35.60 percentage of baseline concentration Standard Deviation 19.987	43.94 percentage of baseline concentration Standard Deviation 10.685	48.57 percentage of baseline concentration Standard Deviation 7.596	—	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4Hours(H))	33.60 percentage of baseline concentration Standard Deviation 34.083	2.10 percentage of baseline concentration Standard Deviation 2.621	0.53 percentage of baseline concentration Standard Deviation 0.869	11.96 percentage of baseline concentration Standard Deviation 26.576	0.40 percentage of baseline concentration Standard Deviation 1.047	-0.25 percentage of baseline concentration Standard Deviation 0.507	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 2	35.60 percentage of baseline concentration Standard Deviation 31.961	2.19 percentage of baseline concentration Standard Deviation 1.297	1.08 percentage of baseline concentration Standard Deviation 0.859	-0.07 percentage of baseline concentration Standard Deviation 0.221	0.10 percentage of baseline concentration Standard Deviation 0.469	0.10 percentage of baseline concentration Standard Deviation 0.141	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 8	53.90 percentage of baseline concentration Standard Deviation 21.355	6.21 percentage of baseline concentration Standard Deviation 6.127	0.94 percentage of baseline concentration Standard Deviation 1.250	0.30 percentage of baseline concentration Standard Deviation 0.306	0.70 percentage of baseline concentration Standard Deviation 1.724	-0.00 percentage of baseline concentration Standard Deviation 0.294	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose)	32.30 percentage of baseline concentration Standard Deviation 11.738	15.21 percentage of baseline concentration Standard Deviation 11.219	3.67 percentage of baseline concentration Standard Deviation 2.511	0.41 percentage of baseline concentration Standard Deviation 0.745	0.88 percentage of baseline concentration Standard Deviation 1.881	-0.03 percentage of baseline concentration Standard Deviation 0.153	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 8	46.35 percentage of baseline concentration Standard Deviation 11.950	10.00 percentage of baseline concentration Standard Deviation 6.387	1.26 percentage of baseline concentration Standard Deviation 1.367	0.04 percentage of baseline concentration Standard Deviation 0.098	0.24 percentage of baseline concentration Standard Deviation 0.720	-0.03 percentage of baseline concentration Standard Deviation 0.058	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose)	19.00 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of free CD4+ central memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.	22.54 percentage of baseline concentration Standard Deviation 20.118	0.44 percentage of baseline concentration Standard Deviation 0.391	-0.07 percentage of baseline concentration Standard Deviation 0.153	0.57 percentage of baseline concentration Standard Deviation 1.069	0.20 percentage of baseline concentration Standard Deviation 0.283	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose)	—	24.3 percentage of baseline concentration Standard Deviation 15.719	0.67 percentage of baseline concentration Standard Deviation 0.603	0.10 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of free CD4+ central memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.	0.80 percentage of baseline concentration Standard Deviation 1.386	-0.25 percentage of baseline concentration Standard Deviation 0.354	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H)	46.55 percentage of baseline concentration Standard Deviation 41.366	3.41 percentage of baseline concentration Standard Deviation 2.948	0.65 percentage of baseline concentration Standard Deviation 0.771	12.92 percentage of baseline concentration Standard Deviation 28.499	0.13 percentage of baseline concentration Standard Deviation 0.333	0.08 percentage of baseline concentration Standard Deviation 0.222	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8	54.70 percentage of baseline concentration Standard Deviation 20.648	19.42 percentage of baseline concentration Standard Deviation 10.402	2.91 percentage of baseline concentration Standard Deviation 2.195	0.23 percentage of baseline concentration Standard Deviation 0.390	0.14 percentage of baseline concentration Standard Deviation 0.385	0.30 percentage of baseline concentration Standard Deviation 0.458	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose)	60.20 percentage of baseline concentration Standard Deviation 24.183	32.47 percentage of baseline concentration Standard Deviation 23.479	3.49 percentage of baseline concentration Standard Deviation 4.759	0.37 percentage of baseline concentration Standard Deviation 0.556	0.16 percentage of baseline concentration Standard Deviation 0.422	-0.05 percentage of baseline concentration Standard Deviation 0.071	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose)	—	32.88 percentage of baseline concentration Standard Deviation 16.059	1.77 percentage of baseline concentration Standard Deviation 1.966	0.00 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of free CD4+ effector memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.	0.37 percentage of baseline concentration Standard Deviation 0.635	-0.15 percentage of baseline concentration Standard Deviation 0.071	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose)	3.00 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of total CD8+ effector memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.	4.66 percentage of baseline concentration Standard Deviation 5.283	5.94 percentage of baseline concentration Standard Deviation 5.734	8.23 percentage of baseline concentration Standard Deviation 4.900	3.33 percentage of baseline concentration Standard Deviation 5.024	2.60 percentage of baseline concentration Standard Deviation 0.990	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H)	3.40 percentage of baseline concentration Standard Deviation 4.384	0.04 percentage of baseline concentration Standard Deviation 0.730	0.65 percentage of baseline concentration Standard Deviation 0.909	3.50 percentage of baseline concentration Standard Deviation 7.275	1.13 percentage of baseline concentration Standard Deviation 1.997	0.28 percentage of baseline concentration Standard Deviation 0.457	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose)	34.10 percentage of baseline concentration Standard Deviation 0.283	40.98 percentage of baseline concentration Standard Deviation 10.428	38.67 percentage of baseline concentration Standard Deviation 8.521	41.20 percentage of baseline concentration Standard Deviation 16.148	46.55 percentage of baseline concentration Standard Deviation 10.978	41.18 percentage of baseline concentration Standard Deviation 8.761	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 8	27.15 percentage of baseline concentration Standard Deviation 4.172	39.53 percentage of baseline concentration Standard Deviation 7.635	37.20 percentage of baseline concentration Standard Deviation 8.902	44.29 percentage of baseline concentration Standard Deviation 11.058	44.80 percentage of baseline concentration Standard Deviation 7.508	42.40 percentage of baseline concentration Standard Deviation 7.165	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose)	31.50 percentage of baseline concentration Standard Deviation 9.051	42.69 percentage of baseline concentration Standard Deviation 14.259	35.62 percentage of baseline concentration Standard Deviation 13.117	42.36 percentage of baseline concentration Standard Deviation 9.707	50.30 percentage of baseline concentration Standard Deviation 10.907	46.75 percentage of baseline concentration Standard Deviation 19.728	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, FOXP3+ Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose)	35.30 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of total FOXP3+ regulatory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.	38.83 percentage of baseline concentration Standard Deviation 8.658	41.89 percentage of baseline concentration Standard Deviation 10.092	35.78 percentage of baseline concentration Standard Deviation 10.316	46.00 percentage of baseline concentration Standard Deviation 11.665	55.70 percentage of baseline concentration Standard Deviation 14.001	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose)	5.40 percentage of baseline concentration Standard Deviation 5.091	6.81 percentage of baseline concentration Standard Deviation 7.484	0.03 percentage of baseline concentration Standard Deviation 0.699	-0.26 percentage of baseline concentration Standard Deviation 0.616	1.52 percentage of baseline concentration Standard Deviation 3.702	-0.40 percentage of baseline concentration Standard Deviation 0.707	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 8	3.00 percentage of baseline concentration Standard Deviation 1.838	5.35 percentage of baseline concentration Standard Deviation 4.214	0.53 percentage of baseline concentration Standard Deviation 0.647	-0.24 percentage of baseline concentration Standard Deviation 1.086	0.44 percentage of baseline concentration Standard Deviation 1.205	-0.87 percentage of baseline concentration Standard Deviation 0.681	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose)	0.90 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of free CD8+ central memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.	5.06 percentage of baseline concentration Standard Deviation 5.735	-0.46 percentage of baseline concentration Standard Deviation 1.561	-0.03 percentage of baseline concentration Standard Deviation 0.231	4.63 percentage of baseline concentration Standard Deviation 8.372	-0.45 percentage of baseline concentration Standard Deviation 0.212	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose)	—	6.55 percentage of baseline concentration Standard Deviation 5.978	0.63 percentage of baseline concentration Standard Deviation 1.274	0.40 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of free CD8+ central memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.	1.90 percentage of baseline concentration Standard Deviation 3.897	-0.60 percentage of baseline concentration Standard Deviation 0.707	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Central Memory T Cells (%) End of treatment	6.10 percentage of baseline concentration Standard Deviation 6.647	9.80 percentage of baseline concentration Standard Deviation 11.895	-0.07 percentage of baseline concentration Standard Deviation 0.115	-0.27 percentage of baseline concentration Standard Deviation 1.396	3.55 percentage of baseline concentration Standard Deviation 5.445	—	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose)	2.55 percentage of baseline concentration Standard Deviation 0.778	3.14 percentage of baseline concentration Standard Deviation 2.932	2.05 percentage of baseline concentration Standard Deviation 1.993	4.57 percentage of baseline concentration Standard Deviation 2.953	3.15 percentage of baseline concentration Standard Deviation 2.473	7.23 percentage of baseline concentration Standard Deviation 8.066	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H)	1.90 percentage of baseline concentration Standard Deviation 0.849	0.06 percentage of baseline concentration Standard Deviation 0.360	0.07 percentage of baseline concentration Standard Deviation 0.216	1.40 percentage of baseline concentration Standard Deviation 2.859	0.57 percentage of baseline concentration Standard Deviation 1.537	0.08 percentage of baseline concentration Standard Deviation 0.050	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8	1.40 percentage of baseline concentration Standard Deviation 0.283	0.50 percentage of baseline concentration Standard Deviation 0.306	-0.01 percentage of baseline concentration Standard Deviation 0.146	0.03 percentage of baseline concentration Standard Deviation 0.198	0.93 percentage of baseline concentration Standard Deviation 2.647	0.00 percentage of baseline concentration Standard Deviation 0.082	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose)	1.85 percentage of baseline concentration Standard Deviation 2.192	2.01 percentage of baseline concentration Standard Deviation 2.507	0.04 percentage of baseline concentration Standard Deviation 0.181	0.01 percentage of baseline concentration Standard Deviation 0.090	1.37 percentage of baseline concentration Standard Deviation 3.300	0.00 percentage of baseline concentration Standard Deviation 0.100	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8	3.20 percentage of baseline concentration Standard Deviation 2.404	1.10 percentage of baseline concentration Standard Deviation 0.868	0.06 percentage of baseline concentration Standard Deviation 0.172	0.06 percentage of baseline concentration Standard Deviation 0.127	0.88 percentage of baseline concentration Standard Deviation 2.080	0.07 percentage of baseline concentration Standard Deviation 0.153	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose)	2.75 percentage of baseline concentration Standard Deviation 1.909	2.90 percentage of baseline concentration Standard Deviation 2.725	0.17 percentage of baseline concentration Standard Deviation 0.309	-0.01 percentage of baseline concentration Standard Deviation 0.135	0.32 percentage of baseline concentration Standard Deviation 0.939	-0.25 percentage of baseline concentration Standard Deviation 0.212	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8	0.65 percentage of baseline concentration Standard Deviation 0.636	2.50 percentage of baseline concentration Standard Deviation 2.571	0.01 percentage of baseline concentration Standard Deviation 0.107	-0.06 percentage of baseline concentration Standard Deviation 0.113	0.86 percentage of baseline concentration Standard Deviation 1.596	0.00 percentage of baseline concentration Standard Deviation 0.100	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose)	2.20 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of free CD8+ effector memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.	3.06 percentage of baseline concentration Standard Deviation 5.099	0.12 percentage of baseline concentration Standard Deviation 0.164	-0.07 percentage of baseline concentration Standard Deviation 0.115	2.40 percentage of baseline concentration Standard Deviation 4.244	0.15 percentage of baseline concentration Standard Deviation 0.071	—	—
Mean Unbound Cell Surface OX40 in Part A1 Free, CD8+ Effector Memory T Cells (%) End of treatment	2.05 percentage of baseline concentration Standard Deviation 1.202	4.77 percentage of baseline concentration Standard Deviation 7.218	0.30 percentage of baseline concentration Standard Deviation 0.624	-0.05 percentage of baseline concentration Standard Deviation 0.058	1.00 percentage of baseline concentration Standard Deviation 1.414	—	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 8	26.85 percentage of baseline concentration Standard Deviation 0.212	36.30 percentage of baseline concentration Standard Deviation 10.886	34.46 percentage of baseline concentration Standard Deviation 11.679	42.89 percentage of baseline concentration Standard Deviation 13.179	40.23 percentage of baseline concentration Standard Deviation 8.245	40.55 percentage of baseline concentration Standard Deviation 9.219	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 8	27.55 percentage of baseline concentration Standard Deviation 3.606	40.33 percentage of baseline concentration Standard Deviation 15.040	38.21 percentage of baseline concentration Standard Deviation 4.342	43.15 percentage of baseline concentration Standard Deviation 9.439	52.44 percentage of baseline concentration Standard Deviation 5.264	35.77 percentage of baseline concentration Standard Deviation 14.935	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose)	28.85 percentage of baseline concentration Standard Deviation 2.758	39.14 percentage of baseline concentration Standard Deviation 12.053	33.46 percentage of baseline concentration Standard Deviation 11.820	37.88 percentage of baseline concentration Standard Deviation 11.844	44.57 percentage of baseline concentration Standard Deviation 13.038	39.25 percentage of baseline concentration Standard Deviation 20.718	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 8	30.40 percentage of baseline concentration Standard Deviation 0.566	34.08 percentage of baseline concentration Standard Deviation 8.806	32.47 percentage of baseline concentration Standard Deviation 13.862	38.61 percentage of baseline concentration Standard Deviation 13.391	41.61 percentage of baseline concentration Standard Deviation 11.904	41.10 percentage of baseline concentration Standard Deviation 15.125	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD127lo Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose)	34.40 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of total, CD127lo regulatory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.	36.50 percentage of baseline concentration Standard Deviation 6.840	36.40 percentage of baseline concentration Standard Deviation 4.627	32.20 percentage of baseline concentration Standard Deviation 7.105	41.88 percentage of baseline concentration Standard Deviation 12.275	35.85 percentage of baseline concentration Standard Deviation 0.354	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD127lo Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose)	—	38.64 percentage of baseline concentration Standard Deviation 5.538	35.20 percentage of baseline concentration Standard Deviation 3.350	25.70 percentage of baseline concentration Standard Deviation 9.051	45.23 percentage of baseline concentration Standard Deviation 9.955	48.25 percentage of baseline concentration Standard Deviation 12.799	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD127lo Regulatory T Cells (%) End of treatment	35.30 percentage of baseline concentration Standard Deviation 2.404	34.00 percentage of baseline concentration Standard Deviation 16.913	28.12 percentage of baseline concentration Standard Deviation 16.961	38.10 percentage of baseline concentration Standard Deviation 10.006	45.20 percentage of baseline concentration Standard Deviation 10.611	—	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)	49.90 percentage of baseline concentration Standard Deviation 3.536	50.61 percentage of baseline concentration Standard Deviation 16.877	44.38 percentage of baseline concentration Standard Deviation 9.798	45.35 percentage of baseline concentration Standard Deviation 13.300	52.28 percentage of baseline concentration Standard Deviation 16.746	33.23 percentage of baseline concentration Standard Deviation 16.607	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4H)	56.45 percentage of baseline concentration Standard Deviation 6.010	52.19 percentage of baseline concentration Standard Deviation 16.212	48.00 percentage of baseline concentration Standard Deviation 14.287	51.86 percentage of baseline concentration Standard Deviation 10.272	44.77 percentage of baseline concentration Standard Deviation 24.667	36.05 percentage of baseline concentration Standard Deviation 16.733	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 2	52.85 percentage of baseline concentration Standard Deviation 11.384	52.74 percentage of baseline concentration Standard Deviation 14.199	48.67 percentage of baseline concentration Standard Deviation 8.943	39.77 percentage of baseline concentration Standard Deviation 12.347	45.11 percentage of baseline concentration Standard Deviation 21.747	21.00 percentage of baseline concentration Standard Deviation 4.101	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose)	49.90 percentage of baseline concentration Standard Deviation 9.758	41.43 percentage of baseline concentration Standard Deviation 14.750	41.21 percentage of baseline concentration Standard Deviation 9.855	45.70 percentage of baseline concentration Standard Deviation 10.567	45.17 percentage of baseline concentration Standard Deviation 16.509	23.30 percentage of baseline concentration Standard Deviation 11.811	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 8	50.85 percentage of baseline concentration Standard Deviation 8.132	49.08 percentage of baseline concentration Standard Deviation 20.277	46.00 percentage of baseline concentration Standard Deviation 7.485	41.00 percentage of baseline concentration Standard Deviation 12.981	34.40 percentage of baseline concentration Standard Deviation 17.363	23.27 percentage of baseline concentration Standard Deviation 26.999	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose)	49.75 percentage of baseline concentration Standard Deviation 13.223	50.04 percentage of baseline concentration Standard Deviation 13.227	40.76 percentage of baseline concentration Standard Deviation 18.801	42.94 percentage of baseline concentration Standard Deviation 11.357	37.22 percentage of baseline concentration Standard Deviation 19.773	35.65 percentage of baseline concentration Standard Deviation 31.183	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 8	54.95 percentage of baseline concentration Standard Deviation 8.839	45.20 percentage of baseline concentration Standard Deviation 16.005	41.20 percentage of baseline concentration Standard Deviation 20.054	42.87 percentage of baseline concentration Standard Deviation 10.049	39.30 percentage of baseline concentration Standard Deviation 13.509	37.37 percentage of baseline concentration Standard Deviation 16.783	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose)	—	53.80 percentage of baseline concentration Standard Deviation 9.098	36.67 percentage of baseline concentration Standard Deviation 2.589	39.90 percentage of baseline concentration Standard Deviation NA There was only one participant with an assessment of total CD4+ central memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.	27.27 percentage of baseline concentration Standard Deviation 23.200	49.00 percentage of baseline concentration Standard Deviation 27.294	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose)	59.60 percentage of baseline concentration Standard Deviation 16.546	56.10 percentage of baseline concentration Standard Deviation 15.093	43.38 percentage of baseline concentration Standard Deviation 23.693	47.03 percentage of baseline concentration Standard Deviation 13.816	40.25 percentage of baseline concentration Standard Deviation 12.277	41.58 percentage of baseline concentration Standard Deviation 15.879	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose)	58.45 percentage of baseline concentration Standard Deviation 18.173	49.54 percentage of baseline concentration Standard Deviation 12.391	51.86 percentage of baseline concentration Standard Deviation 9.906	44.06 percentage of baseline concentration Standard Deviation 12.694	35.20 percentage of baseline concentration Standard Deviation 14.024	30.40 percentage of baseline concentration Standard Deviation 12.382	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8	56.40 percentage of baseline concentration Standard Deviation 15.274	62.78 percentage of baseline concentration Standard Deviation 19.629	51.01 percentage of baseline concentration Standard Deviation 14.110	43.93 percentage of baseline concentration Standard Deviation 14.824	33.48 percentage of baseline concentration Standard Deviation 21.662	31.60 percentage of baseline concentration Standard Deviation 21.458	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose)	56.50 percentage of baseline concentration Standard Deviation 18.526	56.11 percentage of baseline concentration Standard Deviation 14.652	46.63 percentage of baseline concentration Standard Deviation 22.926	43.71 percentage of baseline concentration Standard Deviation 14.276	35.08 percentage of baseline concentration Standard Deviation 19.484	42.35 percentage of baseline concentration Standard Deviation 21.708	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8	60.85 percentage of baseline concentration Standard Deviation 15.344	51.48 percentage of baseline concentration Standard Deviation 21.069	45.60 percentage of baseline concentration Standard Deviation 23.497	42.40 percentage of baseline concentration Standard Deviation 13.966	41.88 percentage of baseline concentration Standard Deviation 16.112	31.67 percentage of baseline concentration Standard Deviation 18.151	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD4+ Effector Memory T Cells (%) End of treatment	62.50 percentage of baseline concentration Standard Deviation 20.789	63.00 percentage of baseline concentration Standard Deviation 21.165	21.43 percentage of baseline concentration Standard Deviation 17.010	29.83 percentage of baseline concentration Standard Deviation 12.258	36.80 percentage of baseline concentration Standard Deviation 12.869	—	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)	7.55 percentage of baseline concentration Standard Deviation 4.879	12.00 percentage of baseline concentration Standard Deviation 10.795	9.02 percentage of baseline concentration Standard Deviation 5.270	16.30 percentage of baseline concentration Standard Deviation 11.546	12.82 percentage of baseline concentration Standard Deviation 4.961	15.63 percentage of baseline concentration Standard Deviation 20.503	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H)	10.35 percentage of baseline concentration Standard Deviation 6.859	11.34 percentage of baseline concentration Standard Deviation 11.046	9.00 percentage of baseline concentration Standard Deviation 5.355	18.72 percentage of baseline concentration Standard Deviation 14.591	10.03 percentage of baseline concentration Standard Deviation 8.477	15.23 percentage of baseline concentration Standard Deviation 15.784	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose)	6.05 percentage of baseline concentration Standard Deviation 4.738	12.11 percentage of baseline concentration Standard Deviation 7.990	10.49 percentage of baseline concentration Standard Deviation 11.153	14.19 percentage of baseline concentration Standard Deviation 9.905	9.86 percentage of baseline concentration Standard Deviation 9.571	6.20 percentage of baseline concentration Standard Deviation 4.525	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 8	6.05 percentage of baseline concentration Standard Deviation 1.626	11.55 percentage of baseline concentration Standard Deviation 8.232	11.29 percentage of baseline concentration Standard Deviation 13.434	13.90 percentage of baseline concentration Standard Deviation 8.309	10.34 percentage of baseline concentration Standard Deviation 8.769	3.00 percentage of baseline concentration Standard Deviation 1.900	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Central Memory T Cells (%) End of treatment	6.85 percentage of baseline concentration Standard Deviation 3.182	13.77 percentage of baseline concentration Standard Deviation 10.845	3.87 percentage of baseline concentration Standard Deviation 5.065	15.08 percentage of baseline concentration Standard Deviation 12.687	9.90 percentage of baseline concentration Standard Deviation 13.576	—	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose)	3.35 percentage of baseline concentration Standard Deviation 2.051	3.66 percentage of baseline concentration Standard Deviation 3.062	3.25 percentage of baseline concentration Standard Deviation 2.091	5.35 percentage of baseline concentration Standard Deviation 4.700	3.82 percentage of baseline concentration Standard Deviation 3.207	24.48 percentage of baseline concentration Standard Deviation 26.779	—	—
Mean Unbound Cell Surface OX40 in Part A1 Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H)	3.80 percentage of baseline concentration Standard Deviation 1.697	4.31 percentage of baseline concentration Standard Deviation 3.611	2.67 percentage of baseline concentration Standard Deviation 2.081	4.86 percentage of baseline concentration Standard Deviation 5.229	2.80 percentage of baseline concentration Standard Deviation 3.454	22.53 percentage of baseline concentration Standard Deviation 26.873	—	—

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=11 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=30 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
ORR Assessed by RECIST Version 1.1 and irRECIST in Part B ORR per RECIST v1.1	0 Percentage of participants	8.3 Percentage of participants	8.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.3 Percentage of participants	—	—
ORR Assessed by RECIST Version 1.1 and irRECIST in Part B ORR per irRECIST	0 Percentage of participants	8.3 Percentage of participants	8.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.3 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=11 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=30 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Kaplan-Meier Estimate of Median PFS in Part B	1.4 months Interval 0.6 to 2.7	2.8 months Interval 0.9 to 4.2	2.3 months Interval 1.4 to 5.5	1.4 months Interval 1.2 to 2.7	1.4 months Interval 1.0 to 2.8	3.2 months Interval 1.7 to 3.7	—	—

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.

TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=11 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=30 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Kaplan-Meier Estimate of Median TTP in Part B	1.4 months Interval 0.6 to 2.7	2.8 months Interval 0.9 to 4.2	2.6 months Interval 1.4 to 5.5	1.4 months Interval 0.9 to 2.7	1.4 months Interval 1.0 to 2.8	3.3 months Interval 1.7 to 4.3	—	—

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.

SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=11 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=30 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Number of Participants Having SD in Part B	2 Participants	5 Participants	4 Participants	4 Participants	3 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=11 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=30 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Kaplan-Meier Estimate of Median DoR in Part B	NA months Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.	NA months Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.	2.8 months Ranges for 95% CI were not estimable due to less than 50% participants in this cohort achieved CR or PR.	NA months Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.	NA months Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.	NA months Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.	—	—

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.

OS was defined as time in weeks or months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 7 or 30.44 if in months.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=11 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=30 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Kaplan-Meier Estimate of Median OS in Part B	8.7 months Interval 2.4 to 14.3	9.5 months Interval 3.9 to 22.1	12.0 months Interval 3.6 to 22.1	11.4 months Interval 1.3 to 21.1	5.4 months Interval 1.2 to 11.4	12.0 months Interval 4.7 to 16.6	—	—

SECONDARY outcome

Timeframe: Baseline up to 24 months post first dose.

Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.

Probability of survival at 6, 12, and 24 months after the first dose of study treatment.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=11 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=30 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Overall Survival Rates at Months 6, 12, and 24 in Part B Survival Probability at Month 24	10.2 Probability of survival Interval 0.6 to 36.4	12.3 Probability of survival Interval 0.7 to 41.4	20.8 Probability of survival Interval 3.2 to 48.7	NA Probability of survival Number and ranges for 95% CI were not estimable due to all 11 participants in the group have been censored or died before month 24.	11.3 Probability of survival Interval 0.6 to 39.1	6.7 Probability of survival Interval 0.5 to 25.1	—	—
Overall Survival Rates at Months 6, 12, and 24 in Part B Survival Probability at Month 6	61.4 Probability of survival Interval 26.6 to 83.5	61.4 Probability of survival Interval 26.6 to 83.5	72.7 Probability of survival Interval 37.1 to 90.3	58.4 Probability of survival Interval 22.7 to 82.3	45.0 Probability of survival Interval 13.9 to 72.4	63.9 Probability of survival Interval 43.2 to 78.8	—	—
Overall Survival Rates at Months 6, 12, and 24 in Part B Survival Probability at Month 12	30.7 Probability of survival Interval 7.3 to 58.6	36.8 Probability of survival Interval 9.3 to 65.7	51.9 Probability of survival Interval 19.8 to 76.7	43.8 Probability of survival Interval 11.8 to 72.7	11.3 Probability of survival Interval 0.6 to 39.1	51.9 Probability of survival Interval 31.8 to 68.8	—	—

SECONDARY outcome

Timeframe: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.

Cmax was defined as maximum observed serum concentration and can be observed directly from data. Css,max was the Cmax on C3D1.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=10 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=10 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=9 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=28 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B CYCLE1/DAY1	2.290 µg/mL Geometric Coefficient of Variation 19	6.965 µg/mL Geometric Coefficient of Variation 23	7.644 µg/mL Geometric Coefficient of Variation 23	19.63 µg/mL Geometric Coefficient of Variation 26	62.45 µg/mL Geometric Coefficient of Variation 31	10.20 µg/mL Geometric Coefficient of Variation 24	—	—
Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B CYCLE3/DAY1	2.779 µg/mL Geometric Coefficient of Variation 29	9.049 µg/mL Geometric Coefficient of Variation 21	9.359 µg/mL Geometric Coefficient of Variation 31	19.76 µg/mL Geometric Coefficient of Variation 45	81.49 µg/mL Geometric Coefficient of Variation 51	10.53 µg/mL Geometric Coefficient of Variation 39	—	—

SECONDARY outcome

AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=10 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=10 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=9 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=28 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE1/DAY1	270.7 µg.hr/mL Geometric Coefficient of Variation 27	1022 µg.hr/mL Geometric Coefficient of Variation 29	1177 µg.hr/mL Geometric Coefficient of Variation 23	3089 µg.hr/mL Geometric Coefficient of Variation 19	10100 µg.hr/mL Geometric Coefficient of Variation 19	1624 µg.hr/mL Geometric Coefficient of Variation 30	—	—
AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE3/DAY1	340.2 µg.hr/mL Geometric Coefficient of Variation 73	1739 µg.hr/mL Geometric Coefficient of Variation 26	2239 µg.hr/mL Geometric Coefficient of Variation 18	4034 µg.hr/mL Geometric Coefficient of Variation 35	19190 µg.hr/mL Geometric Coefficient of Variation 48	2291 µg.hr/mL Geometric Coefficient of Variation 45	—	—

SECONDARY outcome

AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=10 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=10 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=9 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=28 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE1/DAY1	283.5 μg*hr/mL Geometric Coefficient of Variation 31	NA μg*hr/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1380,992.	NA μg*hr/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1800,1700.	—	9480 μg*hr/mL Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	1657 μg*hr/mL Geometric Coefficient of Variation 22	—	—
AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE3/DAY1	NA μg*hr/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 257,228.	—	—	2710 μg*hr/mL Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	—	1130 μg*hr/mL Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	—	—

SECONDARY outcome

t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=10 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=10 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=9 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=28 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE1/DAY1	4.104 days Standard Deviation 1.2263	NA days Standard Deviation NA Mean and Standard Deviation was not calculated for n\<3. And the individual values were 5.58,5.85.	NA days Standard Deviation NA Mean and Standard Deviation was not calculated for n\<3. And the individual values were 6.98,6.1.	—	5.61 days Standard Deviation NA Standard Deviation was not calculated for n\<3.	5.260 days Standard Deviation 0.76772	—	—
t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE3/DAY1	NA days Standard Deviation NA Mean and Standard Deviation was not calculated for n\<3. And the individual values were 2.72,3.16.	—	—	4.72 days Standard Deviation NA Standard Deviation was not calculated for n\<3.	—	3.87 days Standard Deviation NA Standard Deviation was not calculated for n\<3.	—	—

SECONDARY outcome

Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=9 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=10 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=8 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=7 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=26 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B	0.2591 µg/mL Geometric Coefficient of Variation 148	2.266 µg/mL Geometric Coefficient of Variation 39	1.074 µg/mL Geometric Coefficient of Variation 21520	5.327 µg/mL Geometric Coefficient of Variation 101	30.59 µg/mL Geometric Coefficient of Variation 38	2.671 µg/mL Geometric Coefficient of Variation 155	—	—

SECONDARY outcome

Cav was defined as average serum concentration over the dosing interval.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=3 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=7 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=6 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=5 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=5 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=22 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B	1.013 µg/mL Geometric Coefficient of Variation 73	5.175 µg/mL Geometric Coefficient of Variation 26	6.664 µg/mL Geometric Coefficient of Variation 18	12 µg/mL Geometric Coefficient of Variation 35	57.15 µg/mL Geometric Coefficient of Variation 48	6.815 µg/mL Geometric Coefficient of Variation 45	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=3 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=7 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=6 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=5 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=5 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=22 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
CL of PF-04518600 Following Multiple Doses on C3D1 in Part B	0.2944 mL/hr/kg Geometric Coefficient of Variation 73	0.1725 mL/hr/kg Geometric Coefficient of Variation 26	0.1339 mL/hr/kg Geometric Coefficient of Variation 18	0.2481 mL/hr/kg Geometric Coefficient of Variation 35	0.1566 mL/hr/kg Geometric Coefficient of Variation 48	0.1861 mL/hr/kg Geometric Coefficient of Variation 47	—	—

SECONDARY outcome

Vss was defined as volume of distribution at steady state.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=1 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=1 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Vss of PF-04518600 Following Multiple Doses on C3D1 in Part B	NA mL/kg Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 42.6,46.1.	—	—	67.4 mL/kg Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	—	54.3 mL/kg Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	—	—

SECONDARY outcome

Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=3 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=7 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=6 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=5 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=5 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=22 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B	1.374 ratio Geometric Coefficient of Variation 31	1.593 ratio Geometric Coefficient of Variation 26	1.762 ratio Geometric Coefficient of Variation 12	1.361 ratio Geometric Coefficient of Variation 37	1.861 ratio Geometric Coefficient of Variation 31	1.413 ratio Geometric Coefficient of Variation 31	—	—

SECONDARY outcome

Cmax was defined as maximum observed serum concentration and can be observed directly from data. Css,max was the Cmax on C3D1.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=10 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=27 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B CYCLE1/DAY1	4.018 µg/mL Geometric Coefficient of Variation 33	4.06 µg/mL Geometric Coefficient of Variation 39	20.33 µg/mL Geometric Coefficient of Variation 43	17.63 µg/mL Geometric Coefficient of Variation 33	19.02 µg/mL Geometric Coefficient of Variation 29	3.232 µg/mL Geometric Coefficient of Variation 22	—	—
Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B CYCLE3/DAY1	2.909 µg/mL Geometric Coefficient of Variation 47	2.554 µg/mL Geometric Coefficient of Variation 79	20.02 µg/mL Geometric Coefficient of Variation 22	17.94 µg/mL Geometric Coefficient of Variation 39	17.84 µg/mL Geometric Coefficient of Variation 54	2.726 µg/mL Geometric Coefficient of Variation 47	—	—

SECONDARY outcome

AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=10 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=27 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE1/DAY1	789.4 µg•hr/mL Geometric Coefficient of Variation 23	596 µg•hr/mL Geometric Coefficient of Variation 43	2465 µg•hr/mL Geometric Coefficient of Variation 33	2289 µg•hr/mL Geometric Coefficient of Variation 25	2839 µg•hr/mL Geometric Coefficient of Variation 15	561.8 µg•hr/mL Geometric Coefficient of Variation 53	—	—
AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE3/DAY1	NA µg•hr/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 916,464.	343.7 µg•hr/mL Geometric Coefficient of Variation 225	2765 µg•hr/mL Geometric Coefficient of Variation 77	673.9 µg•hr/mL Geometric Coefficient of Variation 1191	2621 µg•hr/mL Geometric Coefficient of Variation 31	232.1 µg•hr/mL Geometric Coefficient of Variation 1524	—	—

SECONDARY outcome

AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=10 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=27 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE1/DAY1	1011 μg*hr/mL Geometric Coefficient of Variation 20	831 μg*hr/mL Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	2801 μg*hr/mL Geometric Coefficient of Variation 25	2252 μg*hr/mL Geometric Coefficient of Variation 34	3137 μg*hr/mL Geometric Coefficient of Variation 15	626.4 μg*hr/mL Geometric Coefficient of Variation 47	—	—
AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE3/DAY1	467 μg*hr/mL Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	—	—	1950 μg*hr/mL Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	NA μg*hr/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 2360,2970.	NA μg*hr/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 624,725.	—	—

SECONDARY outcome

t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=10 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=27 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE1/DAY1	11.37 days Standard Deviation 0.58595	5.44 days Standard Deviation NA Standard Deviation was not calculated for n\<3.	7.769 days Standard Deviation 2.2299	6.873 days Standard Deviation 1.9954	8.27 days Standard Deviation 2.2945	6.632 days Standard Deviation 2.5566	—	—
t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B CYCLE3/DAY1	5.25 days Standard Deviation NA Standard Deviation was not calculated for n\<3.	—	—	2.59 days Standard Deviation NA Standard Deviation was not calculated for n\<3.	NA days Standard Deviation NA Mean and Standard Deviation was not calculated for n\<3. And the individual values were 13,3.88.	NA days Standard Deviation NA Mean and Standard Deviation was not calculated for n\<3. And the individual values were 5.76,5.8.	—	—

SECONDARY outcome

Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=9 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=8 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=9 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=7 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=26 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B	0.03294 µg/mL Geometric Coefficient of Variation 1302300	0.002776 µg/mL Geometric Coefficient of Variation 3859511	0.08612 µg/mL Geometric Coefficient of Variation 1346874	0.0413 µg/mL Geometric Coefficient of Variation 2825205	0.3123 µg/mL Geometric Coefficient of Variation 56629	0.0007531 µg/mL Geometric Coefficient of Variation 117304	—	—

SECONDARY outcome

Cav was defined as average serum concentration over the dosing interval.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=4 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=6 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=5 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=4 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=21 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Cav of Utomilumab Following Multiple Doses on C3D1 in Part B	NA µg/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1.36,0.691.	0.5119 µg/mL Geometric Coefficient of Variation 225	4.119 µg/mL Geometric Coefficient of Variation 77	1.004 µg/mL Geometric Coefficient of Variation 1189	3.903 µg/mL Geometric Coefficient of Variation 31	0.3453 µg/mL Geometric Coefficient of Variation 1524	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=4 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=6 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=5 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=4 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=21 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
CL of Utomilumab Following Multiple Doses on C3D1 in Part B	NA mL/hr/kg Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 0.0218,0.04.	0.05817 mL/hr/kg Geometric Coefficient of Variation 225	0.03615 mL/hr/kg Geometric Coefficient of Variation 77	0.1483 mL/hr/kg Geometric Coefficient of Variation 1187	0.03813 mL/hr/kg Geometric Coefficient of Variation 31	0.08619 mL/hr/kg Geometric Coefficient of Variation 1525	—	—

SECONDARY outcome

Vss was defined as volume of distribution at steady state.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=1 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=1 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=2 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=2 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Vss of Utomilumab Following Multiple Doses on C3D1 in Part B	6.7 mL/kg Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	—	—	4.22 mL/kg Geometric Coefficient of Variation NA Geometric CV was not calculated for n\<3.	NA mL/kg Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 13.4,4.18.	NA mL/kg Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 6.46,5.02.	—	—

SECONDARY outcome

Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=2 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=4 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=6 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=5 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=4 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=21 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Rac of Utomilumab Following Multiple Doses on C3D1 in Part B	NA ratio Geometric Coefficient of Variation NA Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1.23,0.493.	0.5441 ratio Geometric Coefficient of Variation 120	1.091 ratio Geometric Coefficient of Variation 69	0.2673 ratio Geometric Coefficient of Variation 1381	0.9041 ratio Geometric Coefficient of Variation 26	0.391 ratio Geometric Coefficient of Variation 886	—	—

SECONDARY outcome

Timeframe: Baseline up to end of treatment (maximum of 14 weeks).

Population: The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=11 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=11 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=11 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=30 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Number of Participants With ADA and NAb Against PF-04518600 in Part B ADA ever-positive	6 Participants	5 Participants	3 Participants	1 Participants	0 Participants	13 Participants	—	—
Number of Participants With ADA and NAb Against PF-04518600 in Part B NAb ever-positive	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline up to end of treatment (maximum of 14 weeks).

Population: The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.

Outcome measures

Outcome measures
Measure	Part A1: PF-04518600 0.01mg/kg n=10 Participants Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=12 Participants Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=12 Participants Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=9 Participants Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=9 Participants Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=28 Participants Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Number of Participants With ADA and NAb Against Utomilumab in Part B ADA ever-positive	5 Participants	9 Participants	9 Participants	5 Participants	4 Participants	22 Participants	—	—
Number of Participants With ADA and NAb Against Utomilumab in Part B NAb ever-positive	4 Participants	6 Participants	7 Participants	4 Participants	3 Participants	22 Participants	—	—

Adverse Events

Part A1: PF-04518600 0.01mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Part A1: PF-04518600 0.1mg/kg

Serious events: 4 serious events

Other events: 10 other events

Deaths: 7 deaths

Part A1: PF-04518600 0.3mg/kg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 6 deaths

Part A1: PF-04518600 1.5mg/kg

Serious events: 3 serious events

Other events: 12 other events

Deaths: 11 deaths

Part A1: PF-04518600 3.0mg/kg

Serious events: 6 serious events

Other events: 13 other events

Deaths: 10 deaths

Part A1: PF-04518600 10mg/kg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 3 deaths

Part A2: PF-04518600 30mg

Serious events: 7 serious events

Other events: 16 other events

Deaths: 9 deaths

Part A2: PF-04518600 250mg

Serious events: 6 serious events

Other events: 19 other events

Deaths: 9 deaths

Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg

Serious events: 5 serious events

Other events: 11 other events

Deaths: 10 deaths

Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg

Serious events: 2 serious events

Other events: 12 other events

Deaths: 8 deaths

Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg

Serious events: 3 serious events

Other events: 12 other events

Deaths: 10 deaths

Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg

Serious events: 5 serious events

Other events: 11 other events

Deaths: 7 deaths

Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg

Serious events: 5 serious events

Other events: 11 other events

Deaths: 8 deaths

Part B2: PF-04518600 30mg + PF-05082566 20mg

Serious events: 10 serious events

Other events: 29 other events

Deaths: 22 deaths

Serious adverse events

Serious adverse events
Measure	Part A1: PF-04518600 0.01mg/kg n=2 participants at risk Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 participants at risk Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 participants at risk Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 participants at risk Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 participants at risk Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 participants at risk Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 participants at risk Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 participants at risk Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg n=11 participants at risk Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg n=12 participants at risk Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg n=12 participants at risk Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg n=11 participants at risk Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg n=11 participants at risk Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B2: PF-04518600 30mg + PF-05082566 20mg n=30 participants at risk Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Cardiac disorders Acute myocardial infarction	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Bradycardia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Cardiac failure congestive	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Ascites	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Constipation	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Haematemesis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Melaena	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Pancreatitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Vomiting	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Chest pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Hernia pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Performance status decreased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Pyrexia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Cholangitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Biliary tract infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Cellulitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Sepsis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Urinary tract infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood bilirubin increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Gout	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Syncope	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Psychiatric disorders Mental status changes	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Proteinuria	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Vascular purpura	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Myocardial infarction	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Myocardial ischaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Large intestine perforation	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Nausea	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Disease progression	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Euthanasia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Non-cardiac chest pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Oedema peripheral	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Hepatic haemorrhage	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Bacteraemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Pneumonia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Septic shock	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Hemiparesis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Seizure	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Other adverse events

Other adverse events
Measure	Part A1: PF-04518600 0.01mg/kg n=2 participants at risk Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.1mg/kg n=10 participants at risk Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 0.3mg/kg n=11 participants at risk Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 1.5mg/kg n=12 participants at risk Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 3.0mg/kg n=13 participants at risk Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A1: PF-04518600 10mg/kg n=4 participants at risk Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 30mg n=16 participants at risk Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part A2: PF-04518600 250mg n=19 participants at risk Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.	Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg n=11 participants at risk Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg n=12 participants at risk Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg n=12 participants at risk Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg n=11 participants at risk Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg n=11 participants at risk Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.	Part B2: PF-04518600 30mg + PF-05082566 20mg n=30 participants at risk Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	23.1% 3/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.8% 3/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	33.3% 4/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	54.5% 6/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	23.3% 7/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.5% 2/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Bradycardia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Bundle branch block right	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Palpitations	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Pericardial effusion	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Sinus bradycardia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Ear and labyrinth disorders Deafness	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Ear and labyrinth disorders Ear disorder	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Ear and labyrinth disorders Ear pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Ear and labyrinth disorders Hypoacusis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Ear and labyrinth disorders Vertigo	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Endocrine disorders Hypothyroidism	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.5% 2/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Deposit eye	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Eye disorder	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Lacrimation increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Periorbital oedema	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Vision blurred	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Visual impairment	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Abdominal pain	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	30.0% 3/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.8% 3/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	13.3% 4/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.8% 3/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Ascites	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	12.5% 2/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Constipation	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	36.4% 4/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	23.1% 3/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 4/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	36.4% 4/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	36.4% 4/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	13.3% 4/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	33.3% 4/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	26.3% 5/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	26.7% 8/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Dry mouth	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Flatulence	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Haemorrhoids	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Nausea	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	40.0% 4/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	41.7% 5/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.4% 2/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	12.5% 2/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	36.4% 4/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	23.3% 7/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Stomatitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.5% 2/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Toothache	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Vomiting	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	23.1% 3/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	12.5% 2/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 5/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Asthenia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	26.3% 5/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Catheter site erythema	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Chills	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Face oedema	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Facial pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Fatigue	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	70.0% 7/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	54.5% 6/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	38.5% 5/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 4/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	21.1% 4/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	45.5% 5/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	36.7% 11/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Feeling cold	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Gait disturbance	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Influenza like illness	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Mass	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Mucosal inflammation	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Oedema	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Oedema peripheral	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Pyrexia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	30.0% 3/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.4% 2/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Cholangitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Cellulitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Conjunctivitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Cryptosporidiosis infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Gastroenteritis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Gastroenteritis viral	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Gastrointestinal viral infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Herpes virus infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Influenza	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Localised infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Nail infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Nasopharyngitis	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Rhinitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Sinusitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Skin infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Urinary tract infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Vaginal infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Contusion	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Limb injury	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	50.0% 2/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Alanine aminotransferase increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.8% 3/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.5% 2/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 5/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Amylase increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	26.3% 5/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	37.5% 6/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	36.8% 7/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	13.3% 4/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Basophil count increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	12.5% 2/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.5% 2/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood bilirubin increased	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.4% 2/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	12.5% 2/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood creatine phosphokinase increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood creatinine increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.5% 2/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood glucose increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood magnesium decreased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood sodium decreased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood uric acid increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Cardiac murmur	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Electrocardiogram QT prolonged	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Electrocardiogram U-wave abnormality	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Eosinophil count increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Gamma-glutamyltransferase increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	12.5% 2/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	13.3% 4/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Haemoglobin decreased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations International normalised ratio increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Lipase increased	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	12.5% 2/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	21.1% 4/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	13.3% 4/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Lymphocyte count decreased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Neutrophil count decreased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Platelet count increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.5% 2/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Transaminases increased	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Troponin increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Urobilinogen urine increased	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Weight decreased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Weight increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations White blood cell count decreased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations White blood cell count increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Decreased appetite	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	36.4% 4/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	23.1% 3/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	31.2% 5/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	36.4% 4/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	26.7% 8/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Gout	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	23.1% 3/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	13.3% 4/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	13.3% 4/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	50.0% 2/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	30.0% 3/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	13.3% 4/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.4% 2/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	12.5% 2/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.5% 2/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	30.0% 3/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Central nervous system lesion	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Dizziness	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.4% 2/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Encephalopathy	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Haemorrhage intracranial	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Headache	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	36.4% 4/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.4% 2/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.5% 2/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Nervous system disorder	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Sciatica	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Vasogenic cerebral oedema	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Psychiatric disorders Confusional state	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Psychiatric disorders Insomnia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Psychiatric disorders Panic attack	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Chromaturia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Haematuria	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Nocturia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Proteinuria	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Urine flow decreased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Reproductive system and breast disorders Prostatism	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Reproductive system and breast disorders Prostatitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.4% 2/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	13.3% 4/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.0% 2/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	23.1% 3/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	12.5% 2/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	23.3% 7/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.2% 2/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/18 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Acne	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Macule	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	30.0% 3/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	27.3% 3/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 3/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	23.1% 3/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	12.5% 2/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.5% 2/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	23.3% 7/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	31.2% 5/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.8% 3/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	21.1% 4/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	13.3% 4/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Skin adhesion	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Deep vein thrombosis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Embolism	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Hot flush	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Hyperaemia	50.0% 1/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Hypertension	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.4% 2/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	25.0% 1/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	18.8% 3/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.5% 2/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Hypotension	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Intermittent claudication	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 1/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Memory impairment	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Hepatomegaly	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.3% 1/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 1/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Chest pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.2% 1/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Atrial fibrillation	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Tachycardia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Ventricular extrasystoles	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Endocrine disorders Adrenal insufficiency	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Eye pruritus	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Visual acuity reduced	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Xerophthalmia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Dysphagia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Axillary pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Malaise	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Medical device site inflammation	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Cholangitis acute	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Hepatobiliary disease	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Asymptomatic bacteriuria	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Bacterial infection	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Herpes zoster	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Pneumonia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/1 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Stoma site discomfort	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood glucose decreased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood potassium increased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Breath sounds abnormal	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	16.7% 2/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Dysgeusia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Product Issues Device breakage	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Psychiatric disorders Depression	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Psychiatric disorders Sleep disorder	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Bladder irritation	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Dysuria	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Hydronephrosis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Urinary retention	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Papule	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Embolism venous	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Flushing	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Lymphoedema	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Peripheral coldness	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Psychiatric disorders Agitation	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	8.3% 1/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/2 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/10 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/13 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/4 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/16 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/19 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/12 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 1/11 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER