Trial Outcomes & Findings for Study of Mirvetuximab Soravtansine in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab + Carboplatin in Participants With Folate Receptor Alpha (FRα) Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT02606305)

Last Updated: 2024-06-14

Results Overview

Adverse events (AEs) were any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function that developed or worsened during the clinical study, not necessarily having a causal relationship to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Serious AEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes previously listed. TEAEs were any AE that emerged on or after the first dose, and within 30 days of the last dose. Serious and other non-serious AEs regardless of causality are reported in the AE module.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

264 participants

Primary outcome timeframe

From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks)

Results posted on

2024-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Participants were administered mirvetuximab soravtansine 5 milligrams (mg)/kilograms (kg) + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Regimen A Dose Expansion Cohort 3: Pt-agnostic: Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.	Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin area under the time-concentration curve (AUC4) on Day 1 of each 21-day cycle.	Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Participants were administered mirvetuximab soravtansine 5 mg/kg + pegylated liposomal doxorubicin (PLD) 30 mg/meter squared (m\^2) on Day 1 of each 28-day cycle.	Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Dose Escalation: Regimens A, B, C and D STARTED	3	11	0	0	0	4	4	10	4	5	7	4	10	0	0
Dose Escalation: Regimens A, B, C and D Received at Least 1 Dose of Study Drug	3	11	0	0	0	4	4	10	4	5	7	4	10	0	0
Dose Escalation: Regimens A, B, C and D COMPLETED	3	11	0	0	0	4	4	10	4	5	7	4	10	0	0
Dose Escalation: Regimens A, B, C and D NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dose Expansion: Regimens A and D STARTED	0	0	21	34	60	0	0	0	0	0	0	0	0	46	0
Dose Expansion: Regimens A and D Received at Least 1 Dose of Study Drug	0	0	21	34	60	0	0	0	0	0	0	0	0	0	0
Dose Expansion: Regimens A and D COMPLETED	0	0	21	34	60	0	0	0	0	0	0	0	0	0	0
Dose Expansion: Regimens A and D NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	46	0
Triplet Dose: Regimen E STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	41
Triplet Dose: Regimen E Received at Least 1 Dose of Study Drug	0	0	0	0	0	0	0	0	0	0	0	0	0	0	41
Triplet Dose: Regimen E COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	41
Triplet Dose: Regimen E NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Mirvetuximab Soravtansine in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab + Carboplatin in Participants With Folate Receptor Alpha (FRα) Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal, or Fallopian Tube Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=11 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve n=21 Participants Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated n=34 Participants Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Regimen A Dose Expansion Cohort 3: Pt-agnostic: n=60 Participants Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.	Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=5 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=46 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Total n=264 Participants Total of all reporting groups
Age, Continuous	64.3 years STANDARD_DEVIATION 11.85 • n=5 Participants	65.5 years STANDARD_DEVIATION 8.43 • n=7 Participants	62.2 years STANDARD_DEVIATION 7.40 • n=5 Participants	61.4 years STANDARD_DEVIATION 9.99 • n=4 Participants	61.4 years STANDARD_DEVIATION 9.87 • n=21 Participants	59.3 years STANDARD_DEVIATION 9.14 • n=10 Participants	67.0 years STANDARD_DEVIATION 7.07 • n=115 Participants	66.0 years STANDARD_DEVIATION 10.33 • n=24 Participants	59.5 years STANDARD_DEVIATION 12.07 • n=42 Participants	65.2 years STANDARD_DEVIATION 4.66 • n=42 Participants	60.6 years STANDARD_DEVIATION 5.35 • n=42 Participants	58.3 years STANDARD_DEVIATION 6.18 • n=42 Participants	63.5 years STANDARD_DEVIATION 10.81 • n=36 Participants	61.1 years STANDARD_DEVIATION 8.64 • n=36 Participants	63.8 years STANDARD_DEVIATION 9.40 • n=24 Participants	62.3 years STANDARD_DEVIATION 9.16 • n=135 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants	34 Participants n=4 Participants	60 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	10 Participants n=24 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	7 Participants n=42 Participants	4 Participants n=42 Participants	10 Participants n=36 Participants	46 Participants n=36 Participants	41 Participants n=24 Participants	264 Participants n=135 Participants
Sex: Female, Male Male	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=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	1 Participants n=24 Participants	6 Participants n=135 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants	32 Participants n=4 Participants	58 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	9 Participants n=24 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	7 Participants n=42 Participants	4 Participants n=42 Participants	10 Participants n=36 Participants	45 Participants n=36 Participants	39 Participants n=24 Participants	255 Participants n=135 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	3 Participants n=135 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	2 Participants n=135 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	2 Participants n=36 Participants	2 Participants n=24 Participants	7 Participants n=135 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	0 Participants n=24 Participants	2 Participants n=135 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants	32 Participants n=4 Participants	53 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	10 Participants n=24 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	7 Participants n=42 Participants	4 Participants n=42 Participants	10 Participants n=36 Participants	43 Participants n=36 Participants	39 Participants n=24 Participants	249 Participants n=135 Participants
Race (NIH/OMB) More than one race	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=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	4 Participants n=135 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks)

Population: All participants who were enrolled and received at least 1 dose of study drug. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=126 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=5 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=56 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any TEAE	3 Participants	126 Participants	4 Participants	4 Participants	10 Participants	4 Participants	4 Participants	7 Participants	4 Participants	56 Participants	41 Participants	—	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) SAEs	2 Participants	49 Participants	2 Participants	4 Participants	3 Participants	1 Participants	2 Participants	3 Participants	2 Participants	25 Participants	17 Participants	—	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Grade >=3 TEAEs	2 Participants	85 Participants	2 Participants	4 Participants	7 Participants	2 Participants	3 Participants	6 Participants	1 Participants	30 Participants	37 Participants	—	—	—	—

PRIMARY outcome

Timeframe: From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks)

Population: Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose.

ORR was defined as percentage of participants with confirmed response (complete response \[CR\] + partial response \[PR\]). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD. The 95% confidence interval (CI) was based on binomial distribution.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=21 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=34 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=60 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=45 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=41 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Dose Expansion (Regimens A and D) and Triplet (Regimen E): Objective Response Rate (ORR); Percentage of Participants With Confirmed Response, as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	52 percentage of participants Interval 29.78 to 74.29	29 percentage of participants Interval 15.1 to 47.48	50 percentage of participants Interval 36.81 to 63.19	27 percentage of participants Interval 14.6 to 41.94	83 percentage of participants Interval 67.94 to 92.85	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks)

ORR was defined as percentage of participants with confirmed response (CR + PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least 30% decrease in the SLD of target lesions, taking as reference the baseline SLD.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=11 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=9 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=5 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Dose Escalation (Regimens A Through D): ORR; Percentage of Participants With Confirmed Response, as Assessed by RECIST Version 1.1	0 percentage of participants Interval 0.0 to 0.0	45 percentage of participants Interval 16.75 to 76.62	50 percentage of participants Interval 6.76 to 93.24	50 percentage of participants Interval 6.76 to 93.24	89 percentage of participants Interval 51.75 to 99.72	0 percentage of participants Interval 0.0 to 0.0	20 percentage of participants Interval 0.51 to 71.64	29 percentage of participants Interval 3.67 to 70.96	25 percentage of participants Interval 0.63 to 80.59	50 percentage of participants Interval 18.71 to 81.29	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug until the date of PD or death by any cause (maximum exposure: 238.3 weeks)

PFS was defined as the time from the date of the first dose of study drug until the date of PD or death from any cause, whichever occurred first, estimated using the Kaplan-Meier method. PFS was defined based on radiological assessments and determined by the investigator. PD was defined as at least a 20% increase in the SLD of target lesions, taking as reference the smallest (nadir) SLD since and including baseline. In addition to the relative increase of 20%, the SLD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=11 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=21 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=34 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=60 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=9 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=5 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=45 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Progression-Free Survival (PFS); Time From the Date Of First Dose Until The Date Of Progressive Disease (PD) Or Death By Any Cause, As Defined By RECIST Version 1.1	13.49 months Interval 11.76 to Due to smaller number of events, upper 95% CI could not be calculated.	8.80 months Interval 1.18 to Due to smaller number of events, upper 95% CI could not be calculated.	9.92 months Interval 7.13 to Due to smaller number of events, upper 95% CI could not be calculated.	6.77 months Interval 4.63 to 10.71	8.28 months Interval 6.34 to 11.01	13.52 months Interval 10.38 to Due to smaller number of events, upper 95% CI could not be calculated.	32.94 months Interval 10.38 to Due to smaller number of events, upper 95% CI could not be calculated.	16.46 months Interval 6.97 to Due to smaller number of events, upper 95% CI could not be calculated.	NA months Interval 1.68 to Due to smaller number of events, median and upper 95% CI could not be calculated.	7.03 months Interval 0.26 to Due to smaller number of events, upper 95% CI could not be calculated.	7.23 months Interval 1.45 to Due to smaller number of events, upper 95% CI could not be calculated.	2.53 months Interval 1.18 to Due to smaller number of events, upper 95% CI could not be calculated.	9.46 months Interval 1.38 to Due to smaller number of events, upper 95% CI could not be calculated.	4.17 months Interval 2.79 to 5.52	13.50 months Interval 9.86 to 16.3

SECONDARY outcome

Timeframe: From the date of first objective response to the time of PD (maximum exposure: 238.3 weeks)

DOR was defined as the time from the date of the first response (CR or PR), to the date of PD or death from any cause, whichever occurred first. DOR was only defined for patients who had a best overall response of CR or PR, estimated using the Kaplan-Meier method. The response-evaluable population included all patients with radiographic assessment at baseline, who received at least 1 dose of combination treatment and had at least 1 post-dose radiographic tumor assessment or who died within 105 days of first dose.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=5 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=11 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=10 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=30 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=2 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=2 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=8 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=1 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=2 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=1 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=5 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=12 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=34 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Duration of Response (DOR) Per RECIST v1.1 by Investigator Assessment	—	NA months Interval 2.76 to Due to smaller number of events, median and upper 95% CI could not be calculated.	11.96 months Interval 2.99 to Due to smaller number of events, upper 95% CI could not be calculated.	14.06 months Interval 3.91 to Due to smaller number of events, upper 95% CI could not be calculated.	10.38 months Interval 6.93 to 13.67	NA months Interval 6.05 to Due to smaller number of events, median and upper 95% CI could not be calculated.	31.77 months Interval 9.2 to Due to smaller number of events, upper 95% CI could not be calculated.	12.12 months Interval 4.4 to Due to smaller number of events, upper 95% CI could not be calculated.	—	NA months Due to smaller number of events, median and upper 95% CI could not be calculated.	NA months Interval 5.29 to Due to smaller number of events, median and upper 95% CI could not be calculated.	3.42 months Due to smaller number of events, 95% CI could not be calculated.	8.31 months Interval 6.93 to Due to smaller number of events, upper 95% CI could not be calculated.	4.37 months Interval 2.79 to Due to smaller number of events, upper 95% CI could not be calculated.	10.87 months Interval 8.71 to 15.15

SECONDARY outcome

Timeframe: From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks)

Population: CA125 Evaluable Population: All participants whose pretreatment sample is ≥ 2.0 times the upper limit of normal (ULN), within 2 weeks prior to the first dose of combination treatment, and who have at least 1 post-baseline CA125 evaluation.

A CA-125 response was defined as a ≥ 50% reduction in CA-125 levels from baseline. GCIG CA125 response rate was defined as the number of participants with a CA-125 confirmed response divided by the number of participants in the CA-125 response-evaluable population multiplied by 100. The CA-125 evaluable population included all participants whose pretreatment sample was ≥2.0 times the upper limit of normal, within 2 weeks prior to the first dose of combination treatment, and who had at least 1 post-baseline CA-125 evaluation.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=1 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=10 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=16 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=26 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=56 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=2 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=6 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=2 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=8 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=37 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=27 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Gynecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 Clinical Response Rate by Investigator Assessment	100 percentage of participants Interval 2.5 to 100.0	60 percentage of participants Interval 26.2 to 87.8	75 percentage of participants Interval 47.6 to 92.7	65 percentage of participants Interval 44.3 to 82.8	71 percentage of participants Interval 57.8 to 82.7	67 percentage of participants Interval 9.4 to 99.2	100 percentage of participants Interval 29.2 to 100.0	86 percentage of participants Interval 42.1 to 99.6	0 percentage of participants Due to no events, 95% CI could not be calculated.	50 percentage of participants Interval 1.3 to 98.7	50 percentage of participants Interval 11.8 to 88.2	0 percentage of participants Due to no events, 95% CI could not be calculated.	63 percentage of participants Interval 24.5 to 91.5	46 percentage of participants Interval 29.5 to 63.1	100 percentage of participants Interval 87.2 to 100.0

SECONDARY outcome

Timeframe: Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of end of infusion [EOI], and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C)

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Results are reported in micrograms/milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=11 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=20 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=34 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=60 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=5 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=46 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Pharmacokinetics (PK) Parameter: Maximum Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total Antibody Mirvetuximab Soravtansine: Cycle 1	135 µg/mL Geometric Coefficient of Variation 9.2	137 µg/mL Geometric Coefficient of Variation 14.5	159 µg/mL Geometric Coefficient of Variation 30.4	159 µg/mL Geometric Coefficient of Variation 17.2	150 µg/mL Geometric Coefficient of Variation 17.2	118 µg/mL Geometric Coefficient of Variation 15.4	108 µg/mL Geometric Coefficient of Variation 15.7	144 µg/mL Geometric Coefficient of Variation 19.3	115 µg/mL Geometric Coefficient of Variation 21.5	114 µg/mL Geometric Coefficient of Variation 15.8	146 µg/mL Geometric Coefficient of Variation 16.8	112 µg/mL Geometric Coefficient of Variation 4	156 µg/mL Geometric Coefficient of Variation 13.2	151 µg/mL Geometric Coefficient of Variation 17.4	144 µg/mL Geometric Coefficient of Variation 18.5
Pharmacokinetics (PK) Parameter: Maximum Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total Antibody Mirvetuximab Soravtansine: Cycle 3	NA µg/mL Geometric Coefficient of Variation NA Geometric mean Cmax could not be calculated for n\<3	148 µg/mL Geometric Coefficient of Variation 15.8	164 µg/mL Geometric Coefficient of Variation 12.4	174 µg/mL Geometric Coefficient of Variation 14.1	137 µg/mL Geometric Coefficient of Variation 144	46 µg/mL Geometric Coefficient of Variation 999	121 µg/mL Geometric Coefficient of Variation 15.1	147 µg/mL Geometric Coefficient of Variation 12.1	NA µg/mL Geometric Coefficient of Variation NA Geometric mean Cmax could not be calculated for n\<3	137 µg/mL Geometric Coefficient of Variation 15.4	142 µg/mL Geometric Coefficient of Variation 6.03	114 µg/mL Geometric Coefficient of Variation 20	165 µg/mL Geometric Coefficient of Variation 10.6	159 µg/mL Geometric Coefficient of Variation 15.7	128 µg/mL Geometric Coefficient of Variation 66.1
Pharmacokinetics (PK) Parameter: Maximum Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total Antibody Total Antibody: Cycle 1	121 µg/mL Geometric Coefficient of Variation 11.8	122 µg/mL Geometric Coefficient of Variation 12.9	152 µg/mL Geometric Coefficient of Variation 31.1	148 µg/mL Geometric Coefficient of Variation 24.2	153 µg/mL Geometric Coefficient of Variation 13	118 µg/mL Geometric Coefficient of Variation 18.2	102 µg/mL Geometric Coefficient of Variation 16.4	129 µg/mL Geometric Coefficient of Variation 11.8	111 µg/mL Geometric Coefficient of Variation 23.5	114 µg/mL Geometric Coefficient of Variation 18.6	152 µg/mL Geometric Coefficient of Variation 17.2	94.7 µg/mL Geometric Coefficient of Variation 34.2	124 µg/mL Geometric Coefficient of Variation 11.8	146 µg/mL Geometric Coefficient of Variation 16.4	144 µg/mL Geometric Coefficient of Variation 18.3
Pharmacokinetics (PK) Parameter: Maximum Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total Antibody Total Antibody: Cycle 3	NA µg/mL Geometric Coefficient of Variation NA Geometric mean Cmax could not be calculated for n\<3	147 µg/mL Geometric Coefficient of Variation 25.1	177 µg/mL Geometric Coefficient of Variation 26.6	175 µg/mL Geometric Coefficient of Variation 22.7	180 µg/mL Geometric Coefficient of Variation 41	57.9 µg/mL Geometric Coefficient of Variation 238	122 µg/mL Geometric Coefficient of Variation 20.9	149 µg/mL Geometric Coefficient of Variation 15.5	NA µg/mL Geometric Coefficient of Variation NA Geometric mean Cmax could not be calculated for n\<3	124 µg/mL Geometric Coefficient of Variation 3.32	140 µg/mL Geometric Coefficient of Variation 19	114 µg/mL Geometric Coefficient of Variation 17.8	160 µg/mL Geometric Coefficient of Variation 23	165 µg/mL Geometric Coefficient of Variation 17.4	146 µg/mL Geometric Coefficient of Variation 44.2

SECONDARY outcome

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Results are reported in nanograms (ng)/mL.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=11 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=20 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=35 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=60 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=5 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=46 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
PK Parameter: Cmax of N2'-[4-[(3-carboxypropyl)Dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2'-Deacetylmaytansine (DM4) and S-methyl DM4 (SmDM4) DM4: Cycle 1	3.04 ng/mL Geometric Coefficient of Variation 21.8	4.71 ng/mL Geometric Coefficient of Variation 32.9	5.51 ng/mL Geometric Coefficient of Variation 35.8	6.32 ng/mL Geometric Coefficient of Variation 33.8	5.59 ng/mL Geometric Coefficient of Variation 37.5	2.96 ng/mL Geometric Coefficient of Variation 8.85	3.72 ng/mL Geometric Coefficient of Variation 28.7	6.4 ng/mL Geometric Coefficient of Variation 27.7	4.12 ng/mL Geometric Coefficient of Variation 47.5	3.93 ng/mL Geometric Coefficient of Variation 18.3	6.58 ng/mL Geometric Coefficient of Variation 86.4	4.54 ng/mL Geometric Coefficient of Variation 49.3	5.6 ng/mL Geometric Coefficient of Variation 31.2	5.27 ng/mL Geometric Coefficient of Variation 35.3	4.52 ng/mL Geometric Coefficient of Variation 38.4
PK Parameter: Cmax of N2'-[4-[(3-carboxypropyl)Dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2'-Deacetylmaytansine (DM4) and S-methyl DM4 (SmDM4) DM4: Cycle 3	NA ng/mL Geometric Coefficient of Variation NA Geometric mean Cmax could not be calculated for n\<3	5.06 ng/mL Geometric Coefficient of Variation 30.5	4.57 ng/mL Geometric Coefficient of Variation 27.3	6.16 ng/mL Geometric Coefficient of Variation 43.8	5.45 ng/mL Geometric Coefficient of Variation 69.1	3.06 ng/mL Geometric Coefficient of Variation 23.4	3.38 ng/mL Geometric Coefficient of Variation 15	5.66 ng/mL Geometric Coefficient of Variation 31.2	NA ng/mL Geometric Coefficient of Variation NA Geometric mean Cmax could not be calculated for n\<3	5.1 ng/mL Geometric Coefficient of Variation 34.4	7.02 ng/mL Geometric Coefficient of Variation 70.8	3.91 ng/mL Geometric Coefficient of Variation 5.81	4.91 ng/mL Geometric Coefficient of Variation 37.3	4.95 ng/mL Geometric Coefficient of Variation 33.3	4.44 ng/mL Geometric Coefficient of Variation 25.7
PK Parameter: Cmax of N2'-[4-[(3-carboxypropyl)Dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2'-Deacetylmaytansine (DM4) and S-methyl DM4 (SmDM4) S-methyl DM4: Cycle 1	3.61 ng/mL Geometric Coefficient of Variation 26.7	9.6 ng/mL Geometric Coefficient of Variation 65.5	11.5 ng/mL Geometric Coefficient of Variation 61.7	12.2 ng/mL Geometric Coefficient of Variation 68.9	12.2 ng/mL Geometric Coefficient of Variation 62.6	5.75 ng/mL Geometric Coefficient of Variation 56.3	7.91 ng/mL Geometric Coefficient of Variation 46.9	13 ng/mL Geometric Coefficient of Variation 37.5	7.23 ng/mL Geometric Coefficient of Variation 50.8	7.51 ng/mL Geometric Coefficient of Variation 58.1	11.9 ng/mL Geometric Coefficient of Variation 77.1	11.3 ng/mL Geometric Coefficient of Variation 56.6	17 ng/mL Geometric Coefficient of Variation 91.8	12.8 ng/mL Geometric Coefficient of Variation 63.6	8.64 ng/mL Geometric Coefficient of Variation 71.7
PK Parameter: Cmax of N2'-[4-[(3-carboxypropyl)Dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2'-Deacetylmaytansine (DM4) and S-methyl DM4 (SmDM4) S-methyl DM4: Cycle 3	NA ng/mL Geometric Coefficient of Variation NA Geometric mean Cmax could not be calculated for n\<3	12.3 ng/mL Geometric Coefficient of Variation 71.1	11.8 ng/mL Geometric Coefficient of Variation 55.7	12.2 ng/mL Geometric Coefficient of Variation 51.9	12.5 ng/mL Geometric Coefficient of Variation 89.2	3.21 ng/mL Geometric Coefficient of Variation 220	6.79 ng/mL Geometric Coefficient of Variation 59.1	14.1 ng/mL Geometric Coefficient of Variation 43.9	NA ng/mL Geometric Coefficient of Variation NA Geometric mean Cmax could not be calculated for n\<3	10.8 ng/mL Geometric Coefficient of Variation 55.7	17.6 ng/mL Geometric Coefficient of Variation 63	16.2 ng/mL Geometric Coefficient of Variation 11.1	18 ng/mL Geometric Coefficient of Variation 52.9	13 ng/mL Geometric Coefficient of Variation 71.6	9.49 ng/mL Geometric Coefficient of Variation 104

SECONDARY outcome

Timeframe: Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C)

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Results are reported in mg\*hours (h)/mL.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=11 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=20 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=34 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=60 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=4 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=45 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
PK Parameter: Area Under the Time-Concentration Curve From Time 0 To Infinite Time (AUCinf) of Mirvetuximab Soravtansine and Total Antibody Mirvetuximab Soravtansine: Cycle 1	16.1 mg*h/mL Geometric Coefficient of Variation 2.34	17 mg*h/mL Geometric Coefficient of Variation 13.9	18.6 mg*h/mL Geometric Coefficient of Variation 22.2	18.4 mg*h/mL Geometric Coefficient of Variation 22.1	17.5 mg*h/mL Geometric Coefficient of Variation 19.8	14.8 mg*h/mL Geometric Coefficient of Variation 13.8	11.3 mg*h/mL Geometric Coefficient of Variation 23	16.3 mg*h/mL Geometric Coefficient of Variation 26.7	14 mg*h/mL Geometric Coefficient of Variation 23.8	15.2 mg*h/mL Geometric Coefficient of Variation 34.1	16.2 mg*h/mL Geometric Coefficient of Variation 33.1	12.1 mg*h/mL Geometric Coefficient of Variation 19.1	17 mg*h/mL Geometric Coefficient of Variation 30.5	16.9 mg*h/mL Geometric Coefficient of Variation 32.9	17.8 mg*h/mL Geometric Coefficient of Variation 26.3
PK Parameter: Area Under the Time-Concentration Curve From Time 0 To Infinite Time (AUCinf) of Mirvetuximab Soravtansine and Total Antibody Mirvetuximab Soravtansine: Cycle 3	NA mg*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	21.6 mg*h/mL Geometric Coefficient of Variation 37.2	22.7 mg*h/mL Geometric Coefficient of Variation 14.1	22.8 mg*h/mL Geometric Coefficient of Variation 24.9	22.3 mg*h/mL Geometric Coefficient of Variation 16.7	15.2 mg*h/mL Geometric Coefficient of Variation 22.1	17.9 mg*h/mL Geometric Coefficient of Variation 16.1	19.9 mg*h/mL Geometric Coefficient of Variation 26.5	NA mg*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	17.4 mg*h/mL Geometric Coefficient of Variation 19.4	16.4 mg*h/mL Geometric Coefficient of Variation 14.1	14.4 mg*h/mL Geometric Coefficient of Variation 32.1	20.2 mg*h/mL Geometric Coefficient of Variation 28.2	20.9 mg*h/mL Geometric Coefficient of Variation 30.8	19.7 mg*h/mL Geometric Coefficient of Variation 20
PK Parameter: Area Under the Time-Concentration Curve From Time 0 To Infinite Time (AUCinf) of Mirvetuximab Soravtansine and Total Antibody Total Antibody: Cycle 1	NA mg*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	20.6 mg*h/mL Geometric Coefficient of Variation 22.2	24.5 mg*h/mL Geometric Coefficient of Variation 31.4	23.5 mg*h/mL Geometric Coefficient of Variation 34.2	25.8 mg*h/mL Geometric Coefficient of Variation 22	18 mg*h/mL Geometric Coefficient of Variation 22.2	13.3 mg*h/mL Geometric Coefficient of Variation 29	21.6 mg*h/mL Geometric Coefficient of Variation 35.1	20.1 mg*h/mL Geometric Coefficient of Variation 55	17.8 mg*h/mL Geometric Coefficient of Variation 73.5	24.8 mg*h/mL Geometric Coefficient of Variation 26.2	16.8 mg*h/mL Geometric Coefficient of Variation 16.3	18.4 mg*h/mL Geometric Coefficient of Variation 49.1	20 mg*h/mL Geometric Coefficient of Variation 44.6	25 mg*h/mL Geometric Coefficient of Variation 25.4
PK Parameter: Area Under the Time-Concentration Curve From Time 0 To Infinite Time (AUCinf) of Mirvetuximab Soravtansine and Total Antibody Total Antibody: Cycle 3	NA mg*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	24.2 mg*h/mL Geometric Coefficient of Variation 31.3	36.1 mg*h/mL Geometric Coefficient of Variation 23	34.7 mg*h/mL Geometric Coefficient of Variation 49.3	39.2 mg*h/mL Geometric Coefficient of Variation 20.1	NA mg*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	—	30 mg*h/mL Geometric Coefficient of Variation 26	NA mg*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	NA mg*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	29.1 mg*h/mL Geometric Coefficient of Variation 33.6	NA mg*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	20.1 mg*h/mL Geometric Coefficient of Variation 29.7	28.9 mg*h/mL Geometric Coefficient of Variation 55.2	35.8 mg*h/mL Geometric Coefficient of Variation 32.6

SECONDARY outcome

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Note that '9999' is used because AUCinf cannot be calculated for n\<3.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=2 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=10 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=20 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=32 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=57 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=9 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=4 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=46 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=37 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
PK Parameter: AUCinf of Intact DM4 and SmDM4 S-methyl DM4: Cycle 3	NA ng*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	1730 ng*h/mL Geometric Coefficient of Variation 76.3	1620 ng*h/mL Geometric Coefficient of Variation 58.5	1930 ng*h/mL Geometric Coefficient of Variation 52.9	2120 ng*h/mL Geometric Coefficient of Variation 57.8	1130 ng*h/mL Geometric Coefficient of Variation 14.3	1600 ng*h/mL Geometric Coefficient of Variation 49.6	1600 ng*h/mL Geometric Coefficient of Variation 52.4	NA ng*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	1800 ng*h/mL Geometric Coefficient of Variation 80.8	2290 ng*h/mL Geometric Coefficient of Variation 70	NA ng*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	2280 ng*h/mL Geometric Coefficient of Variation 61.9	2080 ng*h/mL Geometric Coefficient of Variation 75.5	1550 ng*h/mL Geometric Coefficient of Variation 61.8
PK Parameter: AUCinf of Intact DM4 and SmDM4 DM4: Cycle 3	NA ng*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	282 ng*h/mL Geometric Coefficient of Variation 14.1	263 ng*h/mL Geometric Coefficient of Variation 31.4	315 ng*h/mL Geometric Coefficient of Variation 36.5	285 ng*h/mL Geometric Coefficient of Variation 27.2	146 ng*h/mL Geometric Coefficient of Variation 22	180 ng*h/mL Geometric Coefficient of Variation 17.4	295 ng*h/mL Geometric Coefficient of Variation 31.3	NA ng*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	200 ng*h/mL Geometric Coefficient of Variation 24.2	289 ng*h/mL Geometric Coefficient of Variation 53.6	163 ng*h/mL Geometric Coefficient of Variation 7.42	245 ng*h/mL Geometric Coefficient of Variation 29.7	260 ng*h/mL Geometric Coefficient of Variation 38.2	243 ng*h/mL Geometric Coefficient of Variation 29.2
PK Parameter: AUCinf of Intact DM4 and SmDM4 S-methyl DM4: Cycle 1	NA ng*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	1700 ng*h/mL Geometric Coefficient of Variation 51.5	1710 ng*h/mL Geometric Coefficient of Variation 73.2	1980 ng*h/mL Geometric Coefficient of Variation 60.7	2120 ng*h/mL Geometric Coefficient of Variation 62.1	1370 ng*h/mL Geometric Coefficient of Variation 49.2	NA ng*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	2160 ng*h/mL Geometric Coefficient of Variation 56.5	1510 ng*h/mL Geometric Coefficient of Variation 63.7	1660 ng*h/mL Geometric Coefficient of Variation 119	1830 ng*h/mL Geometric Coefficient of Variation 72.2	2050 ng*h/mL Geometric Coefficient of Variation 50	2930 ng*h/mL Geometric Coefficient of Variation 91.3	2460 ng*h/mL Geometric Coefficient of Variation 70.8	1830 ng*h/mL Geometric Coefficient of Variation 61.2
PK Parameter: AUCinf of Intact DM4 and SmDM4 DM4: Cycle 1	NA ng*h/mL Geometric Coefficient of Variation NA Geometric mean AUCinf could not be calculated for n\<3	249 ng*h/mL Geometric Coefficient of Variation 12.6	253 ng*h/mL Geometric Coefficient of Variation 28.2	289 ng*h/mL Geometric Coefficient of Variation 30.9	272 ng*h/mL Geometric Coefficient of Variation 28.4	161 ng*h/mL Geometric Coefficient of Variation 15.2	202 ng*h/mL Geometric Coefficient of Variation 21.6	315 ng*h/mL Geometric Coefficient of Variation 55.6	223 ng*h/mL Geometric Coefficient of Variation 64.8	180 ng*h/mL Geometric Coefficient of Variation 19.7	262 ng*h/mL Geometric Coefficient of Variation 49.6	192 ng*h/mL Geometric Coefficient of Variation 33.2	269 ng*h/mL Geometric Coefficient of Variation 17.7	261 ng*h/mL Geometric Coefficient of Variation 31.6	256 ng*h/mL Geometric Coefficient of Variation 40.7

SECONDARY outcome

Timeframe: Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (up to 336 hours) (additionally at Day 22 for Regimen C)

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. PK parameters were calculated using standard non-compartmental methods. The terminal t½ is an estimate (extrapolation) of the time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half (50%). If extrapolated AUC was greater than 20% (due to insufficient number of participants with data samples) the upper range of t½ was not reported.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=11 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=20 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=34 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=60 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=4 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=46 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
PK Parameter: Terminal Half-Life (t½) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Mirvetuximab Soravtansine: Cycle 1	104 h Interval 104.0 to 143.0	123 h Interval 89.5 to 146.0	124 h Interval 76.0 to 154.0	121 h Interval 59.1 to 161.0	126 h Interval 82.1 to 168.0	117 h Interval 97.8 to 119.0	123 h Interval 97.7 to 152.0	128 h Interval 92.5 to 151.0	124 h Interval 114.0 to 176.0	148 h Interval 67.6 to 187.0	137 h Interval 86.2 to 156.0	120 h Interval 115.0 to 135.0	126 h Interval 70.3 to 184.0	126 h Interval 57.5 to 173.0	122 h Interval 85.9 to 172.0
PK Parameter: Terminal Half-Life (t½) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Mirvetuximab Soravtansine: Cycle 3	NA h As per the PK analysis plan, t½ statistics were not calculated when less than 3 individual values were available.	132 h Interval 93.7 to 157.0	132 h Interval 100.0 to 178.0	128 h Interval 65.9 to 181.0	130 h Interval 84.9 to 199.0	124 h Interval 119.0 to 146.0	124 h Interval 116.0 to 161.0	137 h Interval 108.0 to 165.0	NA h As per the PK analysis plan, t½ statistics were not calculated when less than 3 individual values were available.	175 h Interval 76.6 to 237.0	119 h Interval 103.0 to 140.0	114 h Interval 97.8 to 118.0	132 h Interval 99.9 to 173.0	133 h Interval 62.5 to 192.0	140 h Interval 97.6 to 202.0
PK Parameter: Terminal Half-Life (t½) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Total Antibody: Cycle 1	142 h Interval 107.0 to 226.0	206 h Interval 114.0 to 330.0	182 h Interval 87.9 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	221 h Interval 76.2 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	200 h Interval 119.0 to 315.0	189 h Interval 156.0 to 225.0	170 h Interval 165.0 to 286.0	208 h Interval 109.0 to 333.0	231 h Interval 200.0 to 299.0	282 h Interval 80.6 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	249 h Interval 182.0 to 314.0	184 h Interval 168.0 to 209.0	182 h Interval 68.9 to 269.0	196 h Interval 58.0 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	215 h Interval 111.0 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.
PK Parameter: Terminal Half-Life (t½) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Total Antibody: Cycle 3	NA h As per the PK analysis plan, t½ statistics were not calculated when less than 3 individual values were available.	235 h Interval 165.0 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	214 h Interval 127.0 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	228 h Interval 86.8 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	216 h Interval 146.0 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	214 h Interval 143.0 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	290 h Interval 160.0 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	214 h Interval 163.0 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	NA h As per the PK analysis plan, t½ statistics were not calculated when less than 3 individual values were available.	337 h Interval 94.5 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	230 h Interval 88.4 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	197 h Interval 135.0 to 278.0	269 h Interval 170.0 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	232 h Interval 70.3 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	251 h Interval 148.0 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.
PK Parameter: Terminal Half-Life (t½) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 DM4: Cycle 1	49.9 h Interval 40.5 to 121.0	74.4 h Interval 47.8 to 104.0	70.2 h Interval 47.2 to 99.7	61.9 h Interval 43.9 to 100.0	63.9 h Interval 40.1 to 124.0	59.4 h Interval 45.0 to 73.3	60.6 h Interval 40.4 to 124.0	52.4 h Interval 39.6 to 115.0	65.9 h Interval 48.6 to 120.0	55.8 h Interval 51.7 to 65.6	57.4 h Interval 43.0 to 91.4	46.4 h Interval 38.0 to 62.9	73.6 h Interval 42.8 to 131.0	59.4 h Interval 29.8 to 219.0	57.5 h Interval 39.9 to 116.0
PK Parameter: Terminal Half-Life (t½) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 DM4: Cycle 3	NA h As per the PK analysis plan, t½ statistics were not calculated when less than 3 individual values were available.	83.8 h Interval 40.8 to 94.1	73.9 h Interval 32.8 to 102.0	71.1 h Interval 39.4 to 111.0	78.3 h Interval 19.1 to 109.0	68 h Interval 52.3 to 69.6	63.6 h Interval 59.0 to 111.0	74.1 h Interval 52.7 to 101.0	NA h As per the PK analysis plan, t½ statistics were not calculated when less than 3 individual values were available.	96 h Interval 71.7 to 105.0	64.4 h Interval 45.5 to 115.0	46.5 h Interval 41.7 to 65.5	64.6 h Interval 53.3 to 109.0	64 h Interval 33.0 to 161.0	63 h Interval 45.2 to 109.0
PK Parameter: Terminal Half-Life (t½) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 S-methyl DM4: Cycle 1	NA h As per the PK analysis plan, t½ statistics were not calculated when less than 3 individual values were available.	132 h Interval 97.0 to 178.0	126 h Interval 97.8 to 245.0	129 h Interval 81.7 to 217.0	139 h Interval 94.1 to 209.0	128 h Interval 96.0 to 151.0	NA h As per the PK analysis plan, t½ statistics were not calculated when less than 3 individual values were available.	132 h Interval 99.2 to 165.0	168 h Interval 133.0 to 220.0	181 h Interval 156.0 to 285.0	154 h Interval 126.0 to NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.	132 h Interval 106.0 to 169.0	134 h Interval 104.0 to 163.0	127 h Interval 73.4 to 253.0	126 h Interval 84.4 to 292.0
PK Parameter: Terminal Half-Life (t½) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 S-methyl DM4: Cycle 3	NA h As per the PK analysis plan, t½ statistics were not calculated when less than 3 individual values were available.	128 h Interval 97.3 to 216.0	132 h Interval 94.8 to 172.0	126 h Interval 86.7 to 207.0	121 h Interval 79.1 to 196.0	140 h Interval 127.0 to 186.0	168 h Interval 107.0 to 233.0	124 h Interval 100.0 to 155.0	NA h As per the PK analysis plan, t½ statistics were not calculated when less than 3 individual values were available.	182 h Interval 165.0 to 251.0	169 h Interval 105.0 to 213.0	171 h Interval 130.0 to 192.0	148 h Interval 120.0 to 158.0	140 h Interval 88.3 to 253.0	138 h Interval 84.9 to 275.0

SECONDARY outcome

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=11 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=20 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=34 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=60 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=4 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=45 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
PK Parameter: Clearance (CL) of Mirvetuximab Soravtansine and Total Antibody Mirvetuximab Soravtansine: Cycle 1	19.2 mL/h Geometric Coefficient of Variation 18.8	22 mL/h Geometric Coefficient of Variation 17.2	22 mL/h Geometric Coefficient of Variation 29.1	20.9 mL/h Geometric Coefficient of Variation 23.3	23.4 mL/h Geometric Coefficient of Variation 23.8	19.9 mL/h Geometric Coefficient of Variation 10.1	28.9 mL/h Geometric Coefficient of Variation 17	22 mL/h Geometric Coefficient of Variation 26.1	21.2 mL/h Geometric Coefficient of Variation 22.3	23.3 mL/h Geometric Coefficient of Variation 38.6	24.5 mL/h Geometric Coefficient of Variation 41.3	29.2 mL/h Geometric Coefficient of Variation 17.1	23.9 mL/h Geometric Coefficient of Variation 34.5	22.8 mL/h Geometric Coefficient of Variation 34.5	22.1 mL/h Geometric Coefficient of Variation 26.8
PK Parameter: Clearance (CL) of Mirvetuximab Soravtansine and Total Antibody Mirvetuximab Soravtansine: Cycle 3	NA mL/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	16.9 mL/h Geometric Coefficient of Variation 34.4	17.7 mL/h Geometric Coefficient of Variation 23	16.5 mL/h Geometric Coefficient of Variation 26.9	18.3 mL/h Geometric Coefficient of Variation 21.4	19.3 mL/h Geometric Coefficient of Variation 17.9	18.2 mL/h Geometric Coefficient of Variation 14	17.2 mL/h Geometric Coefficient of Variation 24.9	NA mL/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	20.3 mL/h Geometric Coefficient of Variation 23.9	24.3 mL/h Geometric Coefficient of Variation 21.4	26.4 mL/h Geometric Coefficient of Variation 25	18.3 mL/h Geometric Coefficient of Variation 36.8	17.7 mL/h Geometric Coefficient of Variation 35.6	19.2 mL/h Geometric Coefficient of Variation 23.6
PK Parameter: Clearance (CL) of Mirvetuximab Soravtansine and Total Antibody Total Antibody: Cycle 1	NA mL/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	18 mL/h Geometric Coefficient of Variation 23.8	17.5 mL/h Geometric Coefficient of Variation 36.5	16.7 mL/h Geometric Coefficient of Variation 33.9	16.3 mL/h Geometric Coefficient of Variation 25.9	16.3 mL/h Geometric Coefficient of Variation 19.8	24.5 mL/h Geometric Coefficient of Variation 24.6	16.6 mL/h Geometric Coefficient of Variation 36.1	14.7 mL/h Geometric Coefficient of Variation 47.1	19.3 mL/h Geometric Coefficient of Variation 83.4	15.7 mL/h Geometric Coefficient of Variation 34.6	21.1 mL/h Geometric Coefficient of Variation 15.2	22.6 mL/h Geometric Coefficient of Variation 49.2	20 mL/h Geometric Coefficient of Variation 44.7	16.1 mL/h Geometric Coefficient of Variation 26.7
PK Parameter: Clearance (CL) of Mirvetuximab Soravtansine and Total Antibody Total Antibody: Cycle 3	NA mL/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	15 mL/h Geometric Coefficient of Variation 34.3	11.7 mL/h Geometric Coefficient of Variation 27.3	11.2 mL/h Geometric Coefficient of Variation 43.3	10.7 mL/h Geometric Coefficient of Variation 26	NA mL/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	—	11.1 mL/h Geometric Coefficient of Variation 20.5	NA mL/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	NA mL/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	13.9 mL/h Geometric Coefficient of Variation 40.5	NA mL/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	16.4 mL/h Geometric Coefficient of Variation 63.9	12.9 mL/h Geometric Coefficient of Variation 57.5	9.69 mL/h Geometric Coefficient of Variation 38.1

SECONDARY outcome

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=2 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=10 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=20 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=32 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=57 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=9 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=4 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=43 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=37 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
PK Parameter: CL of DM4 and SmDM4 DM4: Cycle 1	NA L/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	29 L/h Geometric Coefficient of Variation 19.3	30.9 L/h Geometric Coefficient of Variation 31.5	25.2 L/h Geometric Coefficient of Variation 36.6	28.6 L/h Geometric Coefficient of Variation 33.3	35 L/h Geometric Coefficient of Variation 14.6	30.7 L/h Geometric Coefficient of Variation 26.8	21.8 L/h Geometric Coefficient of Variation 64.7	25.1 L/h Geometric Coefficient of Variation 59.3	37.4 L/h Geometric Coefficient of Variation 28.3	28.2 L/h Geometric Coefficient of Variation 52.2	35.5 L/h Geometric Coefficient of Variation 57.2	28.8 L/h Geometric Coefficient of Variation 30.7	27.7 L/h Geometric Coefficient of Variation 27.5	29.1 L/h Geometric Coefficient of Variation 40.4
PK Parameter: CL of DM4 and SmDM4 DM4: Cycle 3	NA L/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	23.5 L/h Geometric Coefficient of Variation 26.4	28.9 L/h Geometric Coefficient of Variation 33	22.7 L/h Geometric Coefficient of Variation 39.7	27.2 L/h Geometric Coefficient of Variation 35.5	38.6 L/h Geometric Coefficient of Variation 16	34.5 L/h Geometric Coefficient of Variation 23.4	22.1 L/h Geometric Coefficient of Variation 45.8	NA L/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	33.5 L/h Geometric Coefficient of Variation 41.5	26.6 L/h Geometric Coefficient of Variation 54.3	44.6 L/h Geometric Coefficient of Variation 22.3	28.8 L/h Geometric Coefficient of Variation 44.4	26.7 L/h Geometric Coefficient of Variation 31.8	29.5 L/h Geometric Coefficient of Variation 31.5
PK Parameter: CL of DM4 and SmDM4 S-methyl DM4: Cycle 1	NA L/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	4.49 L/h Geometric Coefficient of Variation 40.2	4.77 L/h Geometric Coefficient of Variation 61.1	3.84 L/h Geometric Coefficient of Variation 57.9	3.82 L/h Geometric Coefficient of Variation 60.8	4.39 L/h Geometric Coefficient of Variation 52	NA L/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	3.35 L/h Geometric Coefficient of Variation 70.6	3.9 L/h Geometric Coefficient of Variation 59.6	4.21 L/h Geometric Coefficient of Variation 119	4.17 L/h Geometric Coefficient of Variation 62.8	3.42 L/h Geometric Coefficient of Variation 73	2.78 L/h Geometric Coefficient of Variation 91.8	3.06 L/h Geometric Coefficient of Variation 63.2	4.25 L/h Geometric Coefficient of Variation 57.1
PK Parameter: CL of DM4 and SmDM4 S-methyl DM4: Cycle 3	NA L/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	4.18 L/h Geometric Coefficient of Variation 66.4	4.97 L/h Geometric Coefficient of Variation 48.6	3.84 L/h Geometric Coefficient of Variation 50.5	3.87 L/h Geometric Coefficient of Variation 52.7	5.19 L/h Geometric Coefficient of Variation 20.3	4.19 L/h Geometric Coefficient of Variation 48.3	4.26 L/h Geometric Coefficient of Variation 59	NA L/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	3.9 L/h Geometric Coefficient of Variation 83.4	3.45 L/h Geometric Coefficient of Variation 56.3	NA L/h Geometric Coefficient of Variation NA Geometric mean CL could not be calculated for n\<3	3.22 L/h Geometric Coefficient of Variation 81.9	3.57 L/h Geometric Coefficient of Variation 63.9	4.78 L/h Geometric Coefficient of Variation 60.4

SECONDARY outcome

Blood samples from participants were analyzed to characterize PK when administered in 3- or 4-week cycles.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=11 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=20 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=34 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=60 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=5 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=45 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
PK Parameter: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Mirvetuximab Soravtansine Cycle 3	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	3.21 L Geometric Coefficient of Variation 14.1	3.25 L Geometric Coefficient of Variation 13.2	2.83 L Geometric Coefficient of Variation 23.3	3.23 L Geometric Coefficient of Variation 23.4	3.37 L Geometric Coefficient of Variation 13.3	3.4 L Geometric Coefficient of Variation 15.7	3.13 L Geometric Coefficient of Variation 12.5	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	3.78 L Geometric Coefficient of Variation 16.6	3.98 L Geometric Coefficient of Variation 19	3.94 L Geometric Coefficient of Variation 15.4	3.28 L Geometric Coefficient of Variation 31	3.1 L Geometric Coefficient of Variation 25.8	3.51 L Geometric Coefficient of Variation 21.6
PK Parameter: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Total Antibody Cycle 1	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	4.38 L Geometric Coefficient of Variation 16.1	4.05 L Geometric Coefficient of Variation 22.7	3.9 L Geometric Coefficient of Variation 34.9	4.06 L Geometric Coefficient of Variation 23.9	4.03 L Geometric Coefficient of Variation 28.1	5.67 L Geometric Coefficient of Variation 10.7	4.27 L Geometric Coefficient of Variation 24.4	4.48 L Geometric Coefficient of Variation 39.2	5.01 L Geometric Coefficient of Variation 1.58	4.09 L Geometric Coefficient of Variation 17.2	5.33 L Geometric Coefficient of Variation 18.7	4.69 L Geometric Coefficient of Variation 23	4.09 L Geometric Coefficient of Variation 30.1	4.21 L Geometric Coefficient of Variation 25.6
PK Parameter: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Total Antibody Cycle 3	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	3.74 L Geometric Coefficient of Variation 23.7	3.17 L Geometric Coefficient of Variation 17.2	2.97 L Geometric Coefficient of Variation 34.6	2.95 L Geometric Coefficient of Variation 24.4	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	—	3.09 L Geometric Coefficient of Variation 8.55	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	3.76 L Geometric Coefficient of Variation 49.6	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	4.01 L Geometric Coefficient of Variation 57.5	3.28 L Geometric Coefficient of Variation 30.5	2.9 L Geometric Coefficient of Variation 25.4
PK Parameter: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 DM4 Cycle 1	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	2590 L Geometric Coefficient of Variation 23.8	2490 L Geometric Coefficient of Variation 31.4	2010 L Geometric Coefficient of Variation 38.6	2240 L Geometric Coefficient of Variation 40.4	2670 L Geometric Coefficient of Variation 20.9	2580 L Geometric Coefficient of Variation 59.4	1720 L Geometric Coefficient of Variation 36	1880 L Geometric Coefficient of Variation 51.6	2730 L Geometric Coefficient of Variation 26.5	2010 L Geometric Coefficient of Variation 53.5	2100 L Geometric Coefficient of Variation 80.9	2410 L Geometric Coefficient of Variation 52.5	2060 L Geometric Coefficient of Variation 31.1	2350 L Geometric Coefficient of Variation 45.1
PK Parameter: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 DM4 Cycle 3	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	2190 L Geometric Coefficient of Variation 20.7	2480 L Geometric Coefficient of Variation 24.3	1990 L Geometric Coefficient of Variation 43.7	2370 L Geometric Coefficient of Variation 35.9	3030 L Geometric Coefficient of Variation 7.84	3160 L Geometric Coefficient of Variation 7.05	1900 L Geometric Coefficient of Variation 55.6	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	3300 L Geometric Coefficient of Variation 38.4	2140 L Geometric Coefficient of Variation 35.9	2930 L Geometric Coefficient of Variation 22.9	2450 L Geometric Coefficient of Variation 53.6	2270 L Geometric Coefficient of Variation 32.8	2450 L Geometric Coefficient of Variation 29.1
PK Parameter: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 SmDM4 Cycle 1	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	911 L Geometric Coefficient of Variation 57.3	900 L Geometric Coefficient of Variation 67.1	731 L Geometric Coefficient of Variation 69.3	751 L Geometric Coefficient of Variation 66.7	932 L Geometric Coefficient of Variation 63.7	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	652 L Geometric Coefficient of Variation 65	832 L Geometric Coefficient of Variation 61.6	1100 L Geometric Coefficient of Variation 114	855 L Geometric Coefficient of Variation 66.3	695 L Geometric Coefficient of Variation 81.2	547 L Geometric Coefficient of Variation 97.6	592 L Geometric Coefficient of Variation 66.4	840 L Geometric Coefficient of Variation 65.1
PK Parameter: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 SmDM4 Cycle 3	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	761 L Geometric Coefficient of Variation 53.6	878 L Geometric Coefficient of Variation 48.6	698 L Geometric Coefficient of Variation 51.8	696 L Geometric Coefficient of Variation 51	1100 L Geometric Coefficient of Variation 1.87	833 L Geometric Coefficient of Variation 24.5	754 L Geometric Coefficient of Variation 60.7	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	947 L Geometric Coefficient of Variation 82.5	773 L Geometric Coefficient of Variation 64.7	NA L Geometric Coefficient of Variation NA Geometric mean Vss could not be calculated for n\<3	621 L Geometric Coefficient of Variation 76.2	709 L Geometric Coefficient of Variation 59.1	891 L Geometric Coefficient of Variation 67.2
PK Parameter: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Mirvetuximab Soravtansine Cycle 1	2.93 L Geometric Coefficient of Variation 18.2	3.63 L Geometric Coefficient of Variation 12.4	3.54 L Geometric Coefficient of Variation 19.7	3.31 L Geometric Coefficient of Variation 18.5	3.87 L Geometric Coefficient of Variation 25.2	3.23 L Geometric Coefficient of Variation 7.04	4.29 L Geometric Coefficient of Variation 11.9	3.52 L Geometric Coefficient of Variation 23.3	3.69 L Geometric Coefficient of Variation 17.9	3.8 L Geometric Coefficient of Variation 10.7	3.88 L Geometric Coefficient of Variation 24.1	4.58 L Geometric Coefficient of Variation 20.9	3.78 L Geometric Coefficient of Variation 21.8	3.59 L Geometric Coefficient of Variation 23.1	3.73 L Geometric Coefficient of Variation 23

SECONDARY outcome

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. PK parameters were derived using non-compartmental PK analysis.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=11 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=20 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=35 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=60 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=5 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=7 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=10 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=46 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
PK Parameter: Time to Reach Cmax (Tmax) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 DM4: Cycle 1	7.2 h Interval 5.52 to 7.27	7.5 h Interval 1.32 to 26.4	7.78 h Interval 1.83 to 8.58	7.63 h Interval 0.0 to 22.4	7.58 h Interval 1.67 to 24.0	7.4 h Interval 1.72 to 7.6	7.56 h Interval 6.0 to 7.78	7.34 h Interval 5.87 to 21.5	7.12 h Interval 5.87 to 7.62	7.32 h Interval 6.0 to 7.53	5.98 h Interval 1.67 to 8.05	7.62 h Interval 7.53 to 7.87	7.7 h Interval 2.25 to 8.22	7.58 h Interval 1.73 to 24.0	7.67 h Interval 1.58 to 8.22
PK Parameter: Time to Reach Cmax (Tmax) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Mirvetuximab Soravtansine: Cycle 1	1.75 h Interval 1.52 to 1.85	1.9 h Interval 1.32 to 7.48	2.1 h Interval 1.63 to 7.8	1.92 h Interval 1.62 to 8.08	2.06 h Interval 1.42 to 24.0	1.68 h Interval 1.63 to 1.72	1.96 h Interval 1.72 to 7.78	1.86 h Interval 1.5 to 7.57	4.28 h Interval 1.22 to 7.62	1.73 h Interval 1.45 to 7.08	5.98 h Interval 1.73 to 8.05	2 h Interval 1.67 to 7.57	2.14 h Interval 1.87 to 7.72	2.12 h Interval 1.62 to 8.23	2.07 h Interval 1.47 to 8.22
PK Parameter: Time to Reach Cmax (Tmax) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Mirvetuximab Soravtansine: Cycle 3	NA h As per the PK analysis plan, Tmax statistics were not calculated when less than 3 individual values were available.	3.88 h Interval 0.967 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.	3.46 h Interval 1.17 to 7.5	2.24 h Interval 1.02 to 7.37	1.49 h Interval 1.08 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.	4.06 h Interval 0.95 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.	1.02 h Interval 0.95 to 5.35	1.48 h Interval 1.07 to 5.97	NA h As per the PK analysis plan, Tmax statistics were not calculated when less than 3 individual values were available.	4.04 h Interval 1.2 to 7.0	6.08 h Interval 1.15 to 7.33	1.45 h Interval 1.17 to 22.0	1.26 h Interval 1.15 to 7.1	1.5 h Interval 0.95 to 25.6	6.98 h Interval 0.95 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.
PK Parameter: Time to Reach Cmax (Tmax) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 S-methyl DM4: Cycle 3	NA h As per the PK analysis plan, Tmax statistics were not calculated when less than 3 individual values were available.	7.01 h Interval 5.83 to 24.6	7.17 h Interval 5.83 to 47.7	7.11 h Interval 5.67 to 48.7	7.41 h Interval 6.02 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.	6.99 h Interval 6.82 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.	15.1 h Interval 5.35 to 47.6	6.08 h Interval 5.03 to 21.3	NA h As per the PK analysis plan, Tmax statistics were not calculated when less than 3 individual values were available.	7.04 h Interval 6.83 to 47.2	7.02 h Interval 6.08 to 7.33	7.1 h Interval 6.87 to 7.6	7.08 h Interval 6.08 to 7.45	7.12 h Interval 0.95 to 47.3	7.22 h Interval 0.95 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.
PK Parameter: Time to Reach Cmax (Tmax) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Total Antibody: Cycle 1	1.75 h Interval 1.52 to 5.52	1.9 h Interval 1.32 to 7.75	2.1 h Interval 1.63 to 25.6	1.9 h Interval 1.62 to 48.2	2.05 h Interval 1.48 to 9.0	1.68 h Interval 1.63 to 24.1	4.09 h Interval 1.72 to 7.78	1.88 h Interval 1.5 to 7.55	3.84 h Interval 1.63 to 6.75	1.87 h Interval 1.45 to 7.53	5.98 h Interval 1.67 to 25.0	4.82 h Interval 1.67 to 7.87	2.25 h Interval 1.88 to 48.9	2.08 h Interval 1.43 to 8.05	2.2 h Interval 1.13 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.
PK Parameter: Time to Reach Cmax (Tmax) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 Total Antibody: Cycle 3	NA h As per the PK analysis plan, Tmax statistics were not calculated when less than 3 individual values were available.	3.88 h Interval 0.967 to 48.9	3.68 h Interval 1.08 to 25.2	2.24 h Interval 1.02 to 27.2	1.49 h Interval 1.08 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.	6.91 h Interval 1.02 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.	1.03 h Interval 0.95 to 7.05	1.48 h Interval 1.17 to 5.83	NA h As per the PK analysis plan, Tmax statistics were not calculated when less than 3 individual values were available.	1.23 h Interval 1.05 to 6.83	7.12 h Interval 6.08 to 49.6	7.1 h Interval 1.05 to 48.7	3.7 h Interval 1.15 to 24.0	1.63 h Interval 0.95 to 25.1	3.03 h Interval 0.967 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.
PK Parameter: Time to Reach Cmax (Tmax) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 DM4: Cycle 3	NA h As per the PK analysis plan, Tmax statistics were not calculated when less than 3 individual values were available.	7 h Interval 1.25 to 7.75	7.06 h Interval 1.25 to 7.63	6.94 h Interval 1.08 to 7.82	6.96 h Interval 1.1 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.	6.99 h Interval 6.82 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.	6.96 h Interval 5.35 to 7.05	6.08 h Interval 5.03 to 7.77	NA h As per the PK analysis plan, Tmax statistics were not calculated when less than 3 individual values were available.	6.89 h Interval 1.2 to 7.0	7.02 h Interval 6.08 to 7.33	7.1 h Interval 1.05 to 7.6	7.08 h Interval 1.33 to 7.45	7.03 h Interval 0.95 to 24.8	7.13 h Interval 0.95 to NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.
PK Parameter: Time to Reach Cmax (Tmax) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4 S-methyl DM4: Cycle 1	23.8 h Interval 7.2 to 119.0	23.9 h Interval 5.87 to 170.0	7.83 h Interval 5.87 to 46.7	7.83 h Interval 5.68 to 166.0	8.26 h Interval 6.05 to 170.0	48.2 h Interval 24.6 to 169.0	108 h Interval 25.4 to 170.0	7.34 h Interval 5.87 to 163.0	23.8 h Interval 6.75 to 23.9	23.8 h Interval 7.53 to 24.4	7.7 h Interval 5.98 to 50.4	7.72 h Interval 7.53 to 49.6	7.84 h Interval 6.17 to 167.0	8 h Interval 7.18 to 171.0	8.15 h Interval 6.93 to 167.0

SECONDARY outcome

Timeframe: At end of infusion (EOI) of Cycle 1; and at pre-infusion and EOI of Cycles 2 to 6

Blood samples from participants at the end of infusion were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=11 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=20 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=33 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=59 Participants Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=40 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Plasma Concentration of Bevacizumab Cycle 1 EOI	368 ug/mL Geometric Coefficient of Variation 20.2	352 ug/mL Geometric Coefficient of Variation 31.9	406 ug/mL Geometric Coefficient of Variation 22.3	430 ug/mL Geometric Coefficient of Variation 19.3	448 ug/mL Geometric Coefficient of Variation 23.2	413 ug/mL Geometric Coefficient of Variation 23.9	—	—	—	—	—	—	—	—	—
Plasma Concentration of Bevacizumab Cycle 2 Pre-infusion	69.3 ug/mL Geometric Coefficient of Variation 37	66 ug/mL Geometric Coefficient of Variation 35.4	90.6 ug/mL Geometric Coefficient of Variation 57.8	87.5 ug/mL Geometric Coefficient of Variation 37.4	88.1 ug/mL Geometric Coefficient of Variation 35	92.5 ug/mL Geometric Coefficient of Variation 39.9	—	—	—	—	—	—	—	—	—
Plasma Concentration of Bevacizumab Cycle 2 EOI	NA ug/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	477 ug/mL Geometric Coefficient of Variation 23.8	429 ug/mL Geometric Coefficient of Variation 38.2	528 ug/mL Geometric Coefficient of Variation 20.8	559 ug/mL Geometric Coefficient of Variation 28.4	473 ug/mL Geometric Coefficient of Variation 44.6	—	—	—	—	—	—	—	—	—
Plasma Concentration of Bevacizumab Cycle 3 Pre-infusion	NA ug/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	79.9 ug/mL Geometric Coefficient of Variation 52.9	132 ug/mL Geometric Coefficient of Variation 17	117 ug/mL Geometric Coefficient of Variation 39.3	118 ug/mL Geometric Coefficient of Variation 51.2	127 ug/mL Geometric Coefficient of Variation 45.8	—	—	—	—	—	—	—	—	—
Plasma Concentration of Bevacizumab Cycle 3 EOI	NA ug/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	408 ug/mL Geometric Coefficient of Variation 59.2	540 ug/mL Geometric Coefficient of Variation 23.6	556 ug/mL Geometric Coefficient of Variation 17.8	616 ug/mL Geometric Coefficient of Variation 22.1	531 ug/mL Geometric Coefficient of Variation 33.1	—	—	—	—	—	—	—	—	—
Plasma Concentration of Bevacizumab Cycle 4 Pre-infusion	NA ug/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	133 ug/mL Geometric Coefficient of Variation 24.1	134 ug/mL Geometric Coefficient of Variation 51.1	141 ug/mL Geometric Coefficient of Variation 49.4	123 ug/mL Geometric Coefficient of Variation 78.2	132 ug/mL Geometric Coefficient of Variation 92.9	—	—	—	—	—	—	—	—	—
Plasma Concentration of Bevacizumab Cycle 4 EOI	NA ug/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	537 ug/mL Geometric Coefficient of Variation 25.2	539 ug/mL Geometric Coefficient of Variation 20.7	505 ug/mL Geometric Coefficient of Variation 39.1	584 ug/mL Geometric Coefficient of Variation 35.7	485 ug/mL Geometric Coefficient of Variation 128	—	—	—	—	—	—	—	—	—
Plasma Concentration of Bevacizumab Cycle 5 Pre-infusion	NA ug/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	134 ug/mL Geometric Coefficient of Variation 18.3	163 ug/mL Geometric Coefficient of Variation 28.9	151 ug/mL Geometric Coefficient of Variation 36.1	137 ug/mL Geometric Coefficient of Variation 61	153 ug/mL Geometric Coefficient of Variation 51	—	—	—	—	—	—	—	—	—
Plasma Concentration of Bevacizumab Cycle 5 EOI	NA ug/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	583 ug/mL Geometric Coefficient of Variation 31.1	565 ug/mL Geometric Coefficient of Variation 19.1	587 ug/mL Geometric Coefficient of Variation 20.3	558 ug/mL Geometric Coefficient of Variation 80.6	547 ug/mL Geometric Coefficient of Variation 24.1	—	—	—	—	—	—	—	—	—
Plasma Concentration of Bevacizumab Cycle 6 Pre-infusion	NA ug/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	80.7 ug/mL Geometric Coefficient of Variation 96.8	191 ug/mL Geometric Coefficient of Variation 27.6	149 ug/mL Geometric Coefficient of Variation 37.8	166 ug/mL Geometric Coefficient of Variation 29.6	170 ug/mL Geometric Coefficient of Variation 51.5	—	—	—	—	—	—	—	—	—
Plasma Concentration of Bevacizumab Cycle 6 EOI	NA ug/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	513 ug/mL Geometric Coefficient of Variation 29.1	574 ug/mL Geometric Coefficient of Variation 26.2	559 ug/mL Geometric Coefficient of Variation 23.9	654 ug/mL Geometric Coefficient of Variation 24.6	525 ug/mL Geometric Coefficient of Variation 39.8	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At end of infusion, 6 and 24 hours post-infusion of Cycle 1; and at pre-infusion and end of infusion of Cycles 2, 4, 5 and 6; at pre-infusion, end of infusion and 6 and 24 hours post-infusion of Cycle 3

Blood samples from participants at the end of infusion were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=4 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=9 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=41 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Plasma Concentration of Carboplatin Cycle 1: EOI	10300 ng/mL Geometric Coefficient of Variation 11.3	1060 ng/mL Geometric Coefficient of Variation 35.2	13900 ng/mL Geometric Coefficient of Variation 19	11800 ng/mL Geometric Coefficient of Variation 25.6	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 1: 6 hours post-infusion	2890 ng/mL Geometric Coefficient of Variation 45.6	3790 ng/mL Geometric Coefficient of Variation 10.3	3120 ng/mL Geometric Coefficient of Variation 151	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 1 24 hours post-infusion	719 ng/mL Geometric Coefficient of Variation 4.77	913 ng/mL Geometric Coefficient of Variation 19.7	1030 ng/mL Geometric Coefficient of Variation 43.8	817 ng/mL Geometric Coefficient of Variation 35	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 2: Pre-infusion	124 ng/mL Geometric Coefficient of Variation 14.8	142 ng/mL Geometric Coefficient of Variation 21.7	158 ng/mL Geometric Coefficient of Variation 13.5	170 ng/mL Geometric Coefficient of Variation 79.2	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 2: EOI	10800 ng/mL Geometric Coefficient of Variation 22	11600 ng/mL Geometric Coefficient of Variation 18.5	11700 ng/mL Geometric Coefficient of Variation 80.9	11000 ng/mL Geometric Coefficient of Variation 146	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 3: Pre-infusion	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	245 ng/mL Geometric Coefficient of Variation 34.6	173 ng/mL Geometric Coefficient of Variation 35.9	203 ng/mL Geometric Coefficient of Variation 28.2	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 3: EOI	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	4170 ng/mL Geometric Coefficient of Variation 946	12100 ng/mL Geometric Coefficient of Variation 28.9	12300 ng/mL Geometric Coefficient of Variation 26.9	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 3: 6 hours post-infusion	1140 ng/mL Geometric Coefficient of Variation 412	3890 ng/mL Geometric Coefficient of Variation 29.9	1630 ng/mL Geometric Coefficient of Variation 238	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 3: 24 hours post-infusion	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	1330 ng/mL Geometric Coefficient of Variation 27.3	1270 ng/mL Geometric Coefficient of Variation 41.3	1440 ng/mL Geometric Coefficient of Variation 49	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 4: Pre-infusion	220 ng/mL Geometric Coefficient of Variation 31.8	243 ng/mL Geometric Coefficient of Variation 59.1	214 ng/mL Geometric Coefficient of Variation 20.6	250 ng/mL Geometric Coefficient of Variation 39.9	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 4: EOI	8230 ng/mL Geometric Coefficient of Variation 43.9	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	214 ng/mL Geometric Coefficient of Variation 20.6	12500 ng/mL Geometric Coefficient of Variation 29.9	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 5: Pre-infusion	199 ng/mL Geometric Coefficient of Variation 41.8	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	194 ng/mL Geometric Coefficient of Variation 37.9	270 ng/mL Geometric Coefficient of Variation 43	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 5: EOI	10900 ng/mL Geometric Coefficient of Variation 36.9	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	13800 ng/mL Geometric Coefficient of Variation 31.8	11200 ng/mL Geometric Coefficient of Variation 88.1	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 6: Pre-infusion	251 ng/mL Geometric Coefficient of Variation 20.2	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	234 ng/mL Geometric Coefficient of Variation 24.6	271 ng/mL Geometric Coefficient of Variation 45.4	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Carboplatin Cycle 6: EOI	12100 ng/mL Geometric Coefficient of Variation 32.5	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	12100 ng/mL Geometric Coefficient of Variation 32.1	10700 ng/mL Geometric Coefficient of Variation 77.9	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At end of infusion of Cycle 1; and at pre-infusion and end of infusion of Cycles 2 to 6

Blood samples from participants at the end of infusion were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=4 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=5 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=7 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Plasma Concentration of Pegylated Liposomal Doxorubicin Cycle 2: EOI	17300 ng/mL Geometric Coefficient of Variation 17.1	25700 ng/mL Geometric Coefficient of Variation 6.88	26100 ng/mL Geometric Coefficient of Variation 12.1	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Pegylated Liposomal Doxorubicin Cycle 1: EOI	18700 ng/mL Geometric Coefficient of Variation 8.72	24400 ng/mL Geometric Coefficient of Variation 14.3	26400 ng/mL Geometric Coefficient of Variation 7.85	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Pegylated Liposomal Doxorubicin Cycle 2: Pre-infusion	—	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	226 ng/mL Geometric Coefficient of Variation 44.9	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Pegylated Liposomal Doxorubicin Cycle 3: Pre-infusion	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	228 ng/mL Geometric Coefficient of Variation 63	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Pegylated Liposomal Doxorubicin Cycle 3: EOI	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	26200 ng/mL Geometric Coefficient of Variation 12.8	26200 ng/mL Geometric Coefficient of Variation 14.3	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Pegylated Liposomal Doxorubicin Cycle 4: Pre-infusion	—	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	151 ng/mL Geometric Coefficient of Variation 54.2	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Pegylated Liposomal Doxorubicin Cycle 4: EOI	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	24300 ng/mL Geometric Coefficient of Variation 24.1	24400 ng/mL Geometric Coefficient of Variation 15.4	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Pegylated Liposomal Doxorubicin Cycle 5: Pre-infusion	—	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	177 ng/mL Geometric Coefficient of Variation 81.1	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Pegylated Liposomal Doxorubicin Cycle 5: EOI	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	23700 ng/mL Geometric Coefficient of Variation 17.1	25000 ng/mL Geometric Coefficient of Variation 11.3	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Pegylated Liposomal Doxorubicin Cycle 6: Pre-infusion	—	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	157 ng/mL Geometric Coefficient of Variation 134	—	—	—	—	—	—	—	—	—	—	—	—
Plasma Concentration of Pegylated Liposomal Doxorubicin Cycle 6: EOI	NA ng/mL Geometric Coefficient of Variation NA Geometric mean plasma concentration could not be calculated for n\<3	22900 ng/mL Geometric Coefficient of Variation 13.3	24600 ng/mL Geometric Coefficient of Variation 14.7	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 283.3 weeks)

Population: The immunogenicity population included all participants who received at least 1 dose of study drug and have evaluable immunogenicity data. As per analysis plan, all regimens (arms/groups) were combined for each phase of the study (dose escalation and dose expansion) for analysis of ADA.

Blood samples were collected to measure the presence of ADAs for mirvetuximab soravtansine. Seronegative is defined as a participant that tests negative at all visits. Treatment-emergent ADA is defined as a participant that is seronegative prior to dosing on Day 1 of Cycle 1 and tests positive in both screening and confirmatory assays at one or more subsequent visits. Treatment-unaffected ADA is defined as a participant test positive in both screening and confirmatory assays prior to dosing on Day 1 of Cycle 1 with a post-dose titer increase of less than or equal to 4-fold (based on a 2-fold sample dilution). Treatment-boosted ADA is defined as a participant test positive in both screening and confirmatory assays prior to dosing on Day 1 of Cycle 1 with a post-dose titer increase of more than a 4-fold increase (based on a 2-fold sample dilution).

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=62 Participants Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=202 Participants All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Immunogenicity: Number of Participants With Anti-Drug Antibody (ADA) Response to Mirvetuximab Soravtansine Seronegative	51 Participants	175 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Immunogenicity: Number of Participants With Anti-Drug Antibody (ADA) Response to Mirvetuximab Soravtansine Treatment-emergent ADA	3 Participants	11 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Immunogenicity: Number of Participants With Anti-Drug Antibody (ADA) Response to Mirvetuximab Soravtansine Treatment-unaffected ADA	7 Participants	11 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—
Immunogenicity: Number of Participants With Anti-Drug Antibody (ADA) Response to Mirvetuximab Soravtansine Treatment-boosted ADA	1 Participants	5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—

Deaths: 4 deaths

Mirvetuximab Soravtansine + Bevacizumab + Carboplatin

Serious events: 17 serious events

Other events: 41 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=126 participants at risk All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=4 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=4 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=10 participants at risk Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=5 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=7 participants at risk Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=56 participants at risk All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 participants at risk Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Gastrointestinal disorders Gastric varices	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Small intestinal obstruction	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.6% 7/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	8.9% 5/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Colitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Enterocolitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Intestinal perforation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Nausea	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Ascites	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Colonic fistula	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Constipation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Enteritis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Large intestine perforation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Malignant gastrointestinal obstruction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Oesophagitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Varices oesophageal	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Vomiting	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Sepsis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Urinary tract infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Peritonitis bacterial	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Pneumonia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Bronchitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Abdominal abscess	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Clostridium difficile colitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Clostridium difficile infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Device related infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Encephalitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Enterocolitis infectious	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders General physical health deterioration	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	75.0% 3/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Headache	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Altered state of consciousness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Cognitive disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Encephalopathy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Haemorrhage intracranial	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Overdose	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Blood creatinine increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Confusional state	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Myocardial infarction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chloroma	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Product Issues Device malfunction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Paraneoplastic dermatomyositis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Hypotension	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Hypertension	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Immune system disorders Anaphylactic reaction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders IgA nephropathy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Urinary retention	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Urosepsis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Asthenia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Discomfort	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Malaise	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Pyrexia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Influenza like illness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.

Other adverse events

Other adverse events
Measure	Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg n=3 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg n=126 participants at risk All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 n=4 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 n=4 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 n=10 participants at risk Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 n=4 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 n=5 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 n=7 participants at risk Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.	Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg n=4 participants at risk Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.	Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg n=56 participants at risk All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.	Mirvetuximab Soravtansine + Bevacizumab + Carboplatin n=41 participants at risk Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Respiratory, thoracic and mediastinal disorders Bronchial wall thickening	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Ocular hyperaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Increased viscosity of bronchial secretion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Oropharyngeal blistering	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Optic atrophy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Lung opacity	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Nasal disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Optic disc drusen	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Headache	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	34.1% 43/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	30.0% 3/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	60.0% 3/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	21.4% 12/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	56.1% 23/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Neuropathy peripheral	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	26.2% 33/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	26.8% 15/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	34.1% 14/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Dysgeusia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	13.5% 17/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 2/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	8.9% 5/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	19.5% 8/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Dizziness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	11.9% 15/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 8/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.1% 7/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	11.1% 14/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	60.0% 6/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	26.8% 15/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.1% 7/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Neurotoxicity	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 9/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Tremor	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Paraesthesia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Cognitive disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Taste disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Lethargy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Amnesia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Burning sensation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Dizziness postural	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Restless legs syndrome	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Sciatica	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Balance disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Dysaesthesia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Dysgraphia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Encephalopathy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Hypogeusia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Migraine with aura	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Memory impairment	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Resting tremor	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Syncope	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Dyskinesia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Essential tremor	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Facial spasm	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Loss of consciousness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Migraine	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Neuralgia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Presyncope	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Nervous system disorders Somnolence	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Vision blurred	66.7% 2/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	56.3% 71/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	75.0% 3/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	75.0% 3/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	60.0% 6/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	60.0% 3/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	42.9% 3/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	46.4% 26/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	75.6% 31/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Dry eye	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	31.0% 39/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 4/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	35.7% 20/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	39.0% 16/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Keratopathy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	29.4% 37/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.9% 10/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	48.8% 20/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Cataract	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	19.8% 25/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 2/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.7% 6/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	26.8% 11/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Visual acuity reduced	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 18/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	19.5% 8/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Photophobia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	12.7% 16/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	12.2% 5/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Eye pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.3% 13/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	16.1% 9/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.1% 7/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Corneal cyst	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	6.3% 8/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Diplopia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Eye irritation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Foreign body sensation in eyes	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Keratitis	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Vitreous floaters	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Corneal deposits	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Visual impairment	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Eye pruritus	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Glaucoma	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Ocular discomfort	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Nausea	66.7% 2/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	57.9% 73/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	100.0% 10/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	80.0% 4/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	85.7% 6/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	75.0% 3/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	53.6% 30/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	80.5% 33/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Angle closure glaucoma	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Aphakia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Astigmatism	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Corneal epithelium defect	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Corneal toxicity	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Eye allergy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Eye haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Glare	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Lacrimation increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Meibomian gland dysfunction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	67.5% 85/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	100.0% 4/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	75.0% 3/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 5/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	75.0% 3/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	80.0% 4/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	57.1% 4/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	57.1% 32/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	82.9% 34/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Vomiting	66.7% 2/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	35.7% 45/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	60.0% 6/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	60.0% 3/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	42.9% 3/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	35.7% 20/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	51.2% 21/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	34.9% 44/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 2/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	32.1% 18/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	56.1% 23/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	26.2% 33/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	16.1% 9/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	24.4% 10/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Constipation	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	26.2% 33/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 4/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	80.0% 4/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 16/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	29.3% 12/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 18/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	16.1% 9/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.6% 6/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	11.1% 14/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 8/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.3% 13/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 8/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	12.2% 5/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Stomatitis	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.5% 12/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	57.1% 4/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.1% 7/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Ascites	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.9% 10/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	12.5% 7/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.8% 6/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.7% 6/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.6% 6/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Colitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Flatulence	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Faeces soft	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Gingival pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Toothache	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Enteritis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Hyperaesthesia teeth	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Abdominal hernia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Anal incontinence	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Dyschezia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Faeces discoloured	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Faeces hard	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Gastric ulcer	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Gastritis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Hiatus hernia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Gastrointestinal mucosa hyperaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Gingival recession	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Glossodynia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Lip pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Oesophageal pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Oesophagitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Rectal discharge	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Rectal fissure	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Tongue discolouration	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Tongue ulceration	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Umbilical hernia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Varices oesophageal	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Anal fissure	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Colonic fistula	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Defaecation urgency	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Dental caries	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Enterocolitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Gastrointestinal angiectasia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Lip dry	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Melaena	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Noninfective gingivitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Oral mucosal hypertrophy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Oral pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Retching	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Salivary duct inflammation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Teeth brittle	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Tooth loss	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Fatigue	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	53.2% 67/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	70.0% 7/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	80.0% 4/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	57.1% 4/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	100.0% 4/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 28/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	73.2% 30/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Asthenia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	19.0% 24/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Pyrexia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 18/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	8.9% 5/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Early satiety	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.5% 12/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Oedema peripheral	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	8.7% 11/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.7% 6/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.1% 7/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Chills	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 9/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Non-cardiac chest pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Catheter site pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Chest discomfort	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Gait disturbance	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Influenza like illness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Mucosal inflammation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Peripheral swelling	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Administration site extravasation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Generalised oedema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Axillary pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Catheter site bruise	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Catheter site discolouration	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Catheter site erythema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Catheter site haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Catheter site injury	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Catheter site mass	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Catheter site pruritus	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Catheter site swelling	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Chest pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Extravasation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Face oedema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders General physical health deterioration	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Implant site dehiscence	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Localised oedema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Malaise	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	8.9% 5/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Pelvic mass	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Sense of oppression	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Thirst	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Catheter site rash	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Catheter site thrombosis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Cyst	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Feeling cold	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Feeling hot	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Injection site bruising	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Medical device site pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Oedema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Physical deconditioning	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Secretion discharge	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Temperature intolerance	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Vaccination site erythema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Vaccination site oedema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
General disorders Vaccination site pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.4% 32/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 14/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	29.3% 12/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	23.0% 29/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	22.0% 9/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	19.8% 25/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	75.0% 3/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 4/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	42.9% 3/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	21.4% 12/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	29.3% 12/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	19.0% 24/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	22.0% 9/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 18/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 2/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	19.6% 11/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	19.5% 8/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.5% 12/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	12.2% 5/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.5% 12/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	12.2% 5/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	6.3% 8/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.8% 6/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.8% 6/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	12.2% 5/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Pinguecula	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Pterygium	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Punctate keratitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Uveitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Vitreous opacities	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Acquired corneal dystrophy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Blepharitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Blepharospasm	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Blindness transient	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Conjunctival haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Conjunctival hyperaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Corneal epithelial microcysts	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Eye discharge	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Eye swelling	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Lenticular opacities	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Maculopathy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Meibomianitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Myopia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Orbital oedema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Photopsia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Posterior capsule opacification	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Retinal drusen	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Trichiasis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Eye disorders Vitreous detachment	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	37.3% 47/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	75.0% 3/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	30.0% 3/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	42.9% 3/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	26.8% 15/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	43.9% 18/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	21.4% 27/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	100.0% 4/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 2/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.7% 6/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	22.0% 9/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	16.7% 21/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	24.4% 10/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.3% 13/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	75.0% 3/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	30.0% 3/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	42.9% 3/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	21.4% 12/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	6.3% 8/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.6% 7/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Polydipsia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.6% 26/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	30.0% 3/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	21.4% 12/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	34.1% 14/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	19.0% 24/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 5/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	23.2% 13/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	26.8% 11/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	15.9% 20/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	16.1% 9/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	19.5% 8/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	13.5% 17/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.7% 6/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.1% 7/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	12.7% 16/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.3% 13/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.7% 6/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.1% 7/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Urinary tract infection	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	23.0% 29/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 2/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	16.1% 9/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	29.3% 12/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Enthesopathy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Enthesophyte	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Muscle discomfort	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	27.0% 34/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	30.0% 3/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	42.9% 3/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	37.5% 21/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	31.7% 13/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Weight decreased	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.4% 32/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 2/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	42.9% 3/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 8/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	26.8% 11/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	24.6% 31/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	30.0% 3/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	42.9% 3/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	33.9% 19/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	24.4% 10/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Hepatitis viral	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.3% 13/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	12.5% 7/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Blood creatinine increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.7% 6/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Albumin urine present	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Weight increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Alanine aminotransferase decreased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Ammonia increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Aspartate aminotransferase decreased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Blood creatine increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Blood pressure increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Cardiac murmur	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Protein urine present	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Transaminases increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Bacterial test	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Blood albumin decreased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Blood potassium increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Body temperature increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations International normalised ratio increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Intraocular pressure increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Lipase increased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Investigations Urine output decreased	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Nasopharyngitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.3% 13/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Sinusitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 9/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 9/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	30.0% 3/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	8.9% 5/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Pneumonia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.8% 6/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	30.0% 3/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Hot flush	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.8% 6/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Oral herpes	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Gingivitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Herpes zoster	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Rhinitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Bronchitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Catheter site infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Conjunctivitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Herpes simplex	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Otitis media	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Pharyngitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Tooth abscess	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Abscess	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Abscess jaw	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Bacteraemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Candida infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Clitoris abscess	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Diverticulitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Ear infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Eye infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Gastroenteritis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Genital herpes	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Hepatitis A	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Localised infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Nail bed infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Osteomyelitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Paronychia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Periodontitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Pyuria	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Respiratory tract infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Stoma site abscess	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Tooth infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Abdominal abscess	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Cellulitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Chronic sinusitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Conjunctivitis viral	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Corneal infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Cystitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Escherichia bacteraemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Fungal infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Fungal skin infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Herpes ophthalmic	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Hordeolum	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Influenza	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Keratitis viral	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Klebsiella infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Laryngitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Nail infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 2/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Ophthalmic herpes simplex	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Oral candidiasis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Papilloma viral infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Parotitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Peritonitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Pulpitis dental	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Rash pustular	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Sepsis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Skin infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Staphylococcal infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Vaginal infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Viral infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Infections and infestations Wound infection	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Hypertension	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	32.5% 41/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	36.6% 15/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Flushing	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.3% 13/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	8.9% 5/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Hypotension	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Lymphoedema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Embolism	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Pelvic venous thrombosis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Peripheral coldness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Phlebitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Vascular disorders Vasculitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	29.4% 37/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	75.0% 3/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	60.0% 6/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	70.7% 29/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	18.3% 23/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	70.0% 7/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	60.0% 3/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	51.2% 21/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	8.7% 11/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 5/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	42.9% 3/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	16.1% 9/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	31.7% 13/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.1% 7/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	8.7% 11/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.9% 10/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Acquired porokeratosis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Butterfly rash	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Chronic pigmented purpura	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Palmar erythema	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Spider naevus	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Nail bed disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Neurodermatitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Onychomadesis	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	60.0% 3/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	28.6% 2/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Papule	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Rash macular	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Skin fragility	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Insomnia	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 18/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.9% 10/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.6% 6/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Anxiety	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	6.3% 8/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.1% 7/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Confusional state	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.8% 6/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Depression	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	40.0% 2/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	12.2% 5/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Agitation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Depressed mood	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Disorientation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Proteinuria	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	13.5% 17/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	12.2% 5/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Dysuria	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Micturition urgency	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Haematuria	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Bladder discomfort	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Micturition disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Nephritis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Renal colic	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Urinary retention	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Urinary tract pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Bladder pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Bladder spasm	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Chromaturia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Leukocyturia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Renal pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Ureterolithiasis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Renal and urinary disorders Urge incontinence	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.6% 7/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.6% 6/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Fall	66.7% 2/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.6% 7/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	17.1% 7/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	50.0% 2/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Cataract operation complication	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Wound complication	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Burns first degree	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Eye contusion	33.3% 1/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Face injury	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Post procedural contusion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Post procedural inflammation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	20.0% 1/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.6% 7/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Cardiac failure	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Breast pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Breast cyst	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Vulva cyst	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Vulval haematoma	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Vulvovaginal inflammation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Dyspareunia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Ear discomfort	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.1% 4/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 3/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Deafness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Motion sickness	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Deafness bilateral	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Ear congestion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Ear pruritus	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Ototoxicity	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.9% 10/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Hepatobiliary disorders Biliary colic	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Hepatobiliary disorders Nodular regenerative hyperplasia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Hepatobiliary disorders Bile duct stone	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Hepatobiliary disorders Cholelithiasis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Hepatobiliary disorders Hepatic pain	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Hepatobiliary disorders Liver disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Hepatobiliary disorders Portal hypertension	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Palpitations	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.0% 5/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	5.4% 3/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	7.3% 3/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Tachycardia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.2% 4/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Angina pectoris	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	25.0% 1/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Endocrine disorders Hypothyroidism	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.6% 2/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	8.9% 5/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Mitral valve disease	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Restrictive cardiomyopathy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Cardiac disorders Tricuspid valve disease	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Product Issues Device occlusion	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Endocrine disorders Cushingoid	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	3.6% 2/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Endocrine disorders Thyroiditis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of skin	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Immune system disorders Contrast media reaction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Immune system disorders Seasonal allergy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Immune system disorders Drug hypersensitivity	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	9.8% 4/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Product Issues Device dislocation	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Social circumstances Corrective lens user	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Surgical and medical procedures Intraocular lens implant	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Irritability	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Nightmare	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Seasonal affective disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Sleep disorder	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.79% 1/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	14.3% 1/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	4.9% 2/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Psychiatric disorders Hallucination	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	2.4% 1/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	10.0% 1/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Acquired corneal dystrophy	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	1.8% 1/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Ear and labyrinth disorders Meibomian gland dysfunction	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/126 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/10 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/7 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/4 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/56 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.	0.00% 0/41 • From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.

Additional Information

CMO, ImmunoGen

ImmunoGen, Inc

Phone: 781-895-0600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place